Effect of proactive therapeutic drug monitoring on maintenance of sustained disease control in adults with rheumatoid arthritis on a subcutaneous TNF inhibitor: The Rheumatoid Arthritis therapeutic DRUg Monitoring trial (RA-DRUM)

Start 20 Aug 2024 · Status Ongoing, recruiting · 5 EU/EEA countries · 21 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Ongoing, recruiting

Participants planned 429

Countries 5

Sites 21

Rheumatoid arthritis

To assess whether proactive TDM is superior to standard of care in order to maintain sustained disease control without flares in patients with RA treated with SC TNFi.

Key facts

Sponsor: Diakonhjemmet Sykehus AS, Medical University Of Vienna, Karolinska University Hospital, University Of Medicine And Pharmacy Carol Davila Bucharest, Humanitas Mirasole S.p.A.
Participant type: Patients
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration: 20 Aug 2024 → ongoing
Decision date (initial): 2024-11-18
Transition trial: No
Low-intervention: Yes
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

To assess whether proactive TDM is superior to standard of care in order to maintain sustained disease control without flares in patients with RA treated with SC TNFi.

Secondary objectives 3

To compare effectiveness of proactive TDM to standard of care on different outcome measures
Safety
To assess whether proactive TDM influences drug survival, drug consumption, occurrence of ADAb, and serum drug levels

Conditions and MedDRA coding

Rheumatoid arthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

A clinical diagnosis of RA
≥ 18 and < 75 years of age at screening
On stable therapy with standard dose of a SC TNFi (adalimumab) for a minimum of 3 months and a maximum of 24 months
In low disease activity or remission (DAS28-CRP < 3.2) and indication for continuation of treatment according to the treating physician
Subject capable of understanding and signing an informed consent form

Exclusion criteria 8

Major comorbidities, such as previous malignancies within the last 5 years, uncontrolled diabetes mellitus, severe infections (including HIV), uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratory diseases, demyelinating disease, significant chronic widespread pain syndrome, significant renal or hepatic disease, and/or other diseases or conditions which either contraindicate treatment with SC TNFi or make adherence to the protocol difficult
Hypersensitivity to SC TNFi (adalimumab)
Pregnancy, or subject considering becoming pregnant during the study period
Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers, or other factors that makes adherence to the study protocol difficult
Changes in csDMARD co-medication, including dose changes of csDMARD or changes in the dose of corticosteroids within the last 2 months
Co-medication with bDMARD, tsDMARD, or other immunosuppressive drugs (excluding csDMARD and corticosteroids ≤ 7.5 mg prednisolone (or equivalent) once daily).
Active participation in any other interventional study
In need of live vaccines during the study period

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Sustained disease control over the follow-up period of 18 months without flare, with flare defined as either of the following: A combination of an increase in Disease Activity Score using 28 joints- C-reactive protein (DAS28-CRP) ≥ 1.2, or ≥ 0.6 if DAS28-CRP ≥ 3.2, AND  2 swollen joints on examination of 44 joints Consensus between participant and physician that disease flare has occurred, leading to a major change in treatment

Secondary endpoints 4

Disease activity at 4, 8, 12, and 18 months
Time to disease flare
Number and type of adverse events (AE)
Drug survival, drug consumption, occurrence of ADAb, serum drug levels

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 33

Humira 40 mg solution for injection in pre-filled syringe

PRD5952368 · Product

Active substance: Adalimumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/03/256/015
MA holder: ABBVIE DEUTSCHLAND GMBH & CO. KG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Humira 40 mg solution for injection in pre-filled pen

PRD5952372 · Product

Active substance: Adalimumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/03/256/019
MA holder: ABBVIE DEUTSCHLAND GMBH & CO. KG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Humira 40 mg solution for injection in pre-filled syringe

PRD5952359 · Product

Active substance: Adalimumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/03/256/005
MA holder: ABBVIE DEUTSCHLAND GMBH & CO. KG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Humira 40 mg solution for injection in pre-filled pen

PRD5952364 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/03/256/010
MA holder: ABBVIE DEUTSCHLAND GMBH & CO. KG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Libmyris 40 mg solution for injection in pre-filled pen

PRD9334785 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/21/1590/003
MA holder: STADA ARZNEIMITTEL AG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Libmyris 40 mg solution for injection in pre-filled pen

PRD9334789 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/21/1590/006
MA holder: STADA ARZNEIMITTEL AG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Idacio 40 mg solution for injection in pre-filled syringe

PRD7500529 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/19/1356/004
MA holder: FRESENIUS KABI DEUTSCHLAND GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Idacio 40 mg solution for injection in pre-filled pen

PRD7500533 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/19/1356/005
MA holder: FRESENIUS KABI DEUTSCHLAND GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Imraldi 40 mg solution for injection in pre-filled pen

PRD5895487 · Product

Active substance: Adalimumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Week(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/17/1216/007
MA holder: SAMSUNG BIOEPIS NL B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Imraldi 40 mg solution for injection in pre-filled syringe

PRD5895410 · Product

Active substance: Adalimumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/17/1216/004
MA holder: SAMSUNG BIOEPIS NL B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Imraldi 40 mg solution for injection in pre-filled pen

PRD5895488 · Product

Active substance: Adalimumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/17/1216/008
MA holder: SAMSUNG BIOEPIS NL B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hulio 40 mg solution for injection in pre-filled pen

PRD11028794 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/18/1319/020
MA holder: BIOSIMILAR COLLABORATIONS IRELAND LIMITED
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hulio 40 mg solution for injection in pre-filled syringe

PRD11028742 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS USE
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/18/1319/003
MA holder: BIOSIMILAR COLLABORATIONS IRELAND LIMITED
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hulio 40 mg solution for injection in pre-filled syringe

PRD11028762 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Week(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/18/1319/015
MA holder: BIOSIMILAR COLLABORATIONS IRELAND LIMITED
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hulio 40 mg solution for injection in pre-filled pen

PRD11028774 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/18/1319/006
MA holder: BIOSIMILAR COLLABORATIONS IRELAND LIMITED
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hefiya 40 mg solution for injection in pre-filled syringe

PRD6500394 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/18/1287/003
MA holder: SANDOZ GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hefiya 40 mg solution for injection in pre-filled pen

PRD6500403 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/18/1287/006
MA holder: SANDOZ GMBH
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hefiya 40 mg solution for injection in pre-filled syringe

PRD10358601 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/18/1287/014
MA holder: SANDOZ GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hefiya 40 mg solution for injection in pre-filled pen

PRD10358605 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/18/1287/018
MA holder: SANDOZ GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

AMGEVITA 40 mg solution for injection in pre-filled syringe

PRD4870358 · Product

Active substance: Adalimumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/16/1164/005
MA holder: AMGEN EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

AMGEVITA 40 mg solution for injection in pre-filled pen

PRD4870361 · Product

Active substance: Adalimumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/16/1164/008
MA holder: AMGEN EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

AMGEVITA 40 mg solution for injection in pre-filled pen

PRD4870362 · Product

Active substance: Adalimumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/16/1164/009
MA holder: AMGEN EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

AMGEVITA 40 mg solution for injection in pre-filled syringe

PRD4870357 · Product

Active substance: Adalimumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/16/1164/004
MA holder: AMGEN EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hyrimoz 40 mg solution for injection in pre-filled syringe

PRD6500391 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/18/1286/003
MA holder: SANDOZ GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hyrimoz 40 mg solution for injection in pre-filled pen

PRD10358554 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/18/1286/018
MA holder: SANDOZ GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hyrimoz 40 mg solution for injection in pre-filled pen

PRD6500400 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/18/1286/006
MA holder: SANDOZ GMBH
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hyrimoz 40 mg solution for injection in pre-filled syringe

PRD10358550 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/18/1286/014
MA holder: SANDOZ GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hyrimoz 40 mg solution for injection in pre-filled syringe

PRD10358548 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/18/1286/012
MA holder: SANDOZ GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hukyndra 40 mg solution for injection in pre-filled syringe

PRD9341000 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/21/1589/003
MA holder: STADA ARZNEIMITTEL AG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hukyndra 40 mg solution for injection in pre-filled pen

PRD9341004 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/21/1589/006
MA holder: STADA ARZNEIMITTEL AG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Yuflyma 40 mg solution for injection in pre-filled pen

PRD8752283 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/20/1513/012
MA holder: CELLTRION HEALTHCARE HUNGARY KFT
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Yuflyma 40 mg solution for injection in pre-filled syringe

PRD8752268 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/20/1513/008
MA holder: CELLTRION HEALTHCARE HUNGARY KFT
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Yuflyma 40 mg solution for injection in pre-filled syringe

PRD8752253 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 18 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/20/1513/004
MA holder: CELLTRION HEALTHCARE HUNGARY KFT
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Diakonhjemmet Sykehus AS

Sponsor organisation: Diakonhjemmet Sykehus AS
Address: Diakonveien 12
City: Oslo
Postcode: 0370
Country: Norway

Scientific contact point

Organisation: Diakonhjemmet Sykehus AS
Contact name: Silje W Syversen

Public contact point

Organisation: Diakonhjemmet Sykehus AS
Contact name: Silje W Syversen

Third parties 2

Organisation	City, country	Duties
Oslo University Hospital HF ORG-100021349	Oslo, Norway	Laboratory analysis
Oslo University Hospital HF ORG-100021349	Oslo, Norway	Other

Medical University Of Vienna

Sponsor organisation: Medical University Of Vienna
Address: Spitalgasse 23, Alsergrund Alsergrund
City: Vienna
Postcode: 1090
Country: Austria

Scientific contact point

Organisation: Medical University Of Vienna
Contact name: Helga Lechner-Radner

Public contact point

Organisation: Medical University Of Vienna
Contact name: Helga Lechner-Radner

Karolinska University Hospital

Sponsor organisation: Karolinska University Hospital
Address: Eugeniavagen 3
City: Solna
Postcode: 171 64
Country: Sweden

Scientific contact point

Organisation: Karolinska University Hospital
Contact name: Katerina Aikaterini Chatzidionysiou

Public contact point

Organisation: Karolinska University Hospital
Contact name: Katerina Aikaterini Chatzidionysiou

University Of Medicine And Pharmacy Carol Davila Bucharest

Sponsor organisation: University Of Medicine And Pharmacy Carol Davila Bucharest
Address: Strada Lupu Dionisie Nr. 37
City: Bucharest
Postcode: 020021
Country: Romania

Scientific contact point

Organisation: University Of Medicine And Pharmacy Carol Davila Bucharest
Contact name: Prof. Catalin Codreanu

Public contact point

Organisation: University Of Medicine And Pharmacy Carol Davila Bucharest
Contact name: Prof. Catalin Codreanu

Humanitas Mirasole S.p.A.

Sponsor organisation: Humanitas Mirasole S.p.A.
Address: Via Alessandro Manzoni 56
City: Rozzano
Postcode: 20089
Country: Italy

Scientific contact point

Organisation: Humanitas Mirasole S.p.A.
Contact name: Elisa Gremese

Public contact point

Organisation: Humanitas Mirasole S.p.A.
Contact name: Elisa Gremese

Sponsor responsibilities

Article 77 compliance: Diakonhjemmet Sykehus AS
Contact point sponsor: Diakonhjemmet Sykehus AS
Article 77 implementation: Diakonhjemmet Sykehus AS

Locations

5 EU/EEA countries · 21 investigational sites

By country

Country	MS status	Planned subjects	Sites
Austria	Ongoing, recruiting	30	1
Italy	Ongoing, recruiting	19	1
Norway	Ongoing, recruiting	291	16
Romania	Ongoing, recruiting	30	1
Sweden	Ongoing, recruiting	40	2
Rest of world United Kingdom	—	19	—

Investigational sites

Austria

1 site · Ongoing, recruiting

Medical University Of Vienna

Division of Rheumatology, Waehringer Guertel 18-20, Alsergrund, Vienna

Italy

1 site · Ongoing, recruiting

Humanitas Mirasole S.p.A.

Division of Rheumatology and Clinical Immunology, Via Alessandro Manzoni 56, 20089, Rozzano

Norway

16 sites · Ongoing, recruiting

Sorlandet Sykehus HF

Rheumatology, Egsveien 100, 4615, Kristiansand S

Revmatismesykehuset AS

Rhumatology, Margrethe Grundtvigs Veg 6, 2609, Lillehammer

Nordlandssykehuset HF

Department of Rheumatology, Medical clinic, Parkveien 95, 8005, Bodo

Ostfold Hospital Trust

Department of Rheumatology, P. O. Box 16, 1603, Fredrikstad

Helse Forde HF

Rheumatologic dept., Svanehaugvegen 2, 6812, Foerde

Helse Bergen HF

Rheumatology Department, P. O. Box 1400, 5021, Bergen

Helse Stavanger HF

Rheumatology department., P. O. Box 8100, 4068, Stavanger

Betanien Hospital

Department of Rheumatology, Bjørnstjerne Bjørnsons gate 6, 3722, Skien

Haugesund Sanitetsforenings Revmatismesykehus AS

partment of Rheumatology, Karmsundgata 134, 5528, Haugesund

Diakonhjemmet Sykehus AS

Clinic for rheumatology, policlinic and research, Diakonveien 12, 0370, Oslo

Helgelandssykehuset HF

Internal medicine, Sjoeforsgata 36, 8613, Mo I Rana

Martina Hansens Hospital AS

Rheumatology, Doenskiveien 8, 1346, Gjettum

Helse Moere Og Romsdal HF

jj, Aasehaugen 5, 6017, Aalesund

Universitetssykehuset Nord-Norge HF

Rheumatology, Sykehusvegen 38, 9019, Tromsoe

Drammen Sykehus

s, Dronninggata 28, 3004, Drammen

St. Olavs Hospital HF

Revmatologisk avdeling, P. O. Box 3250, Torgarden, Trondheim

Romania

1 site · Ongoing, recruiting

Centrul Clinic De Boli Reumatismale Dr. Ion Stoia

Clinical Centre for Rheumatic Diseases, Strada Masaryk Thomas 5, 020983, Bucharest

Sweden

2 sites · Ongoing, recruiting

Karolinska University Hospital

ME Gastro, Hud, Reuma, Rheumatology Unit Department of Medicine, Eugeniavagen 3, 171 64, Solna

Sahlgrenska University Hospital-Vaestra Goetalandsregionen

Clinical Trial Unit, Rheumatology, Sahlgrenska University Hospital, Grona Straket 16, Bla Straket 5, Goteborgs Annedal, Goteborg

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Recruitment start
Austria	2025-04-01	2025-05-15
Italy	2026-01-20	2026-02-03
Norway	2024-08-20	2024-08-26
Romania	2025-03-12	2025-04-10
Sweden	2024-10-15	2024-12-04

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 45 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1 Protocol_2023-510184-35-00	1.0
Protocol (for publication)	D1_Protocol 2023-510184-35-00	1.1
Protocol (for publication)	D4_ Patient facingdocuments_NO	0.9
Protocol (for publication)	D4_ Patient facingdocuments_SV	0.9
Protocol (for publication)	D4_Patient facingdocument_IT	0.9
Protocol (for publication)	D4_Patients Facing Documents_DE	0.91
Recruitment arrangements (for publication)	K1_ Recruitment arrangements	N/A
Recruitment arrangements (for publication)	K1_Recruitment arrangement	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements	0.91
Recruitment arrangements (for publication)	K1_Recruitment arrangements_IT	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements_MUW_Redacted	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements_RO	0.91
Subject information and informed consent form (for publication)	L1 SIS and ICF adults_DE_redacted	1.2
Subject information and informed consent form (for publication)	L1_ SIS and ICF adults	0.9
Subject information and informed consent form (for publication)	L1_ SIS and ICF adults for publication	0.9
Subject information and informed consent form (for publication)	L1_ SIS and ICF adults RO	0.91
Subject information and informed consent form (for publication)	L1_ SIS and ICF adults_ Diakonhjemmet Hospital	0.91
Subject information and informed consent form (for publication)	L1_ SIS and ICF adults_all sites	0.91
Subject information and informed consent form (for publication)	L1_Informativa privacy_Humanitas mirasole spa_Clean_redacted	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF adults	0.91
Subject information and informed consent form (for publication)	L1_SIS and ICF adults_redacted	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Data Protection_Humanitas mirasole spa_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF main_IT Humanitas mirasole spa_Clean_redacted	1.1
Subject information and informed consent form (for publication)	L1-SIS and ICF main_IT Humanitas mirasole spa_redacted	1
Summary of Product Characteristics (SmPC) (for publication)	G2_ SmPC Amgevita	N/A
Summary of Product Characteristics (SmPC) (for publication)	G2_ SmPC Hukyndra	N/A
Summary of Product Characteristics (SmPC) (for publication)	G2_ SmPC Hulio	N/A
Summary of Product Characteristics (SmPC) (for publication)	G2_ SmPC Humira	1
Summary of Product Characteristics (SmPC) (for publication)	G2_ SmPC Hyrimoz	N/A
Summary of Product Characteristics (SmPC) (for publication)	G2_ SmPC Idacio	N/A
Summary of Product Characteristics (SmPC) (for publication)	G2_ SmPC Imraldi	N/A
Summary of Product Characteristics (SmPC) (for publication)	G2_ SmPC Libmyris	N/A
Summary of Product Characteristics (SmPC) (for publication)	G2_ SmPC Libmyris	N/A
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC Yuflyma	N/A
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_D_ 2023-510184-35-00_SM	1.2
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_DE_2023-510184-35-00	1.1
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_ENG_ 2023-510184-35-00_SM	1.2
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_ENG_2023-510184-35-00	1.1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2023-510184-35-00_RO	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_IT 2023-510184-35-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_NO 2023-510184-35-00	0.9
Synopsis of the protocol (for publication)	D1_Protocol synopsis_NO_2023-510184-35-00_SM	1.1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_RO_2023-510184-35-00_SM	1.1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_SV 2023-510184-35-00	0.9
Synopsis of the protocol (for publication)	D1_Protocol synopsis_SV_2023-510184-35-00_SM	1.1

Application history

7 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-01-31	Norway	Acceptable 2024-05-21	2024-05-21
2	SUBSEQUENT ADDITION OF MSC	APP-2	2024-08-20		Acceptable 2024-05-21	2024-11-18
3	SUBSEQUENT ADDITION OF MSC	APP-3	2024-08-20			2024-10-24
4	SUBSTANTIAL MODIFICATION	SM-2	2024-12-09	Norway	Acceptable 2025-03-03	2025-03-05
5	SUBSEQUENT ADDITION OF MSC	APP-5	2025-06-20			2025-09-12
6	SUBSTANTIAL MODIFICATION	SM-3	2026-02-27	Norway	Acceptable	2026-03-10
7	SUBSTANTIAL MODIFICATION	SM-4	2026-04-17	Norway	Acceptable 2026-05-06	2026-05-06

Effect of proactive therapeutic drug monitoring on maintenance of sustained disease control in adults with rheumatoid arthritis on a subcutaneous TNF inhibitor: The Rheumatoid Arthritis therapeutic DRUg Monitoring trial (RA-DRUM)

Overview

Key facts

Trial design

Main objective

Secondary objectives 3

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 5

Exclusion criteria 8

Endpoints

Primary endpoints 1

Secondary endpoints 4

Investigational products

Test 33

Sponsors and contacts

Diakonhjemmet Sykehus AS

Scientific contact point

Public contact point

Third parties 2

Medical University Of Vienna

Scientific contact point

Public contact point

Karolinska University Hospital

Scientific contact point

Public contact point

University Of Medicine And Pharmacy Carol Davila Bucharest

Scientific contact point

Public contact point

Humanitas Mirasole S.p.A.

Scientific contact point

Public contact point

Sponsor responsibilities

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 45 files

Application history

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