Testing the safety and efficacy of combining biologic drugs in Rheumatoid and Psoriatic Arthritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Cardiff University

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2025-07-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Horizon 2020

External identifiers

EU CT number

2024-518011-19-00

ISRCTN

ISRCTN50666516

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

Proportion of patients who achieve disease remission at week 24 will be the primary endpoint. Remission will be defined by:
• Clinical Disease Activity Index (CDAI) 2.8 or < 2.8 in RA
• DAPSA <4 in PsA

Secondary objectives 2

1. Safety will include number of Serious Adverse Events (SAEs), Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and withdrawals due to SAEs, AEs or AESIs. Severe infection requiring hospitalisation will be included as AESI.
2. Disease specific activity scores and percentage improvement in disease activity: • RA will include ACR and EULAR response criteria, change in disease activity scores (CDAI and DASESR scores), physical disability by modified Health Assessment Questionnaire (mHAQ) • PsA will include DAPSA, ACR response, DAS score, PsARC response, physical disability by modified Health Assessment Questionnaire (HAQ) (using mHAQ), Psoriasis Area and Severity Index (PASI) response)

Conditions and MedDRA coding

Psoriatic Arthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Adult patients (≥18 years old), no upper age limit;
2. Patient must fulfil either European Alliance of Associations for Rheumatology (EULAR)/Albumin: Creatinine Ratio (ACR) classification criteria for the diagnosis of Rheumatoid Arthritis, or Classification Criteria of Psoriatic Arthritis (CASPAR);
3. Current treatment with any approved Tumour Necrosis Factor inhibitors (TNFis)
4. Active arthritis as defined by: • DAS28 score > 3.2 for Rheumatoid Arthritis • Disease Activity in Psoriatic Arthritis (DAPSA) >14 for Psoriatic Arthritis
5. Signed informed consent

Exclusion criteria 22

1. Contraindications to any of the biologic treatment e.g. active infection;
2. Previous treatment with any IL-6is (tocilizumab or sarilumab)
3. Women who are pregnant or breast-feeding
4. Women of child-bearing potential, or males whose partners are women of child-bearing potential, unwilling to use effective contraception during the study and for at least 3 months after stopping study treatment
5. History of or current primary inflammatory joint disease or primary autoimmune disease other than RA
6. Intra articular or parenteral corticosteroids ≤ 4 weeks prior Visit 2
7. Oral prednisolone more than 10mg per day or equivalent ≤ 4 weeks prior to Visit 2
8. Active infection
9. Septic arthritis within a native joint within the last 12 months
10. Sepsis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ
11. Known HIV or hepatitis B/C infection (hepatitis B screening test must be performed at or in the preceding 3 months of screening visit)
12. Malignancy (other than basal cell carcinoma) within the last 10 years
13. New York Heart Association (NYHA) grade 3 or 4 congestive cardiac failure
14. Demyelinating disease
15. Any other contra-indication to the study medications as detailed in their summaries of product characteristics (SmPC), including low IgG levels at clinician’s discretion
16. Receipt of live vaccine <4 weeks prior to first infusion
17. Major surgery in 3 months prior to first infusion
18. Presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening)
19. Known recent substance abuse (drug or alcohol)
20. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period
21. Patients currently recruited to other clinical trial(s) involving an Investigational Medicinal Pproduct (IMP), except any observational follow-up periods not involving an IMP)
22. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients who achieve disease remission at week 24 will be the primary endpoint. Remission will be defined by: • Clinical Disease Activity Index (CDAI) 2.8 or < 2.8 in RA • DAPSA <4 in PsA.

Secondary endpoints 2

1. To provide proof-of-principle validation of the efficacy of combining TNF and IL-6 inhibitors achieve higher remission than current therapies in RA and PsA.
2. To provide preliminary safety and tolerability data on the selected combination therapy and improvement in disease activity as measured by validated outcome measures.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cardiff University

Sponsor organisation

Cardiff University

Address

Neuadd Meirionnydd, Heath Park Way, Heath Heath Park Way Heath

City

Cardiff

Postcode

CF14 4YU

Country

United Kingdom

Scientific contact point

Organisation

Cardiff University

Contact name

Professor Ernest Choy

Public contact point

Organisation

Cardiff University

Contact name

Sophie King

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

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

Documents 8 files

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

Application history

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