Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
212
Countries
1
Sites
9
Rheumatoid arthritis
Difference in DAS28 over 12 months of follow-up between patients with newly diagnosed RA randomised to either oral or subcutaneous methotrexat.
Key facts
- Sponsor
- Region Vaesterbotten
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 28 Apr 2022 → ongoing
- Decision date (initial)
- 2024-07-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512453-25-00
- EudraCT number
- 2020-000462-41
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Pharmacoeconomic
Difference in DAS28 over 12 months of follow-up between patients with newly diagnosed RA randomised to either oral or subcutaneous methotrexat.
Secondary objectives 8
- Drug retention after 24 months
- Treatment-efficacy in other aspects
- Number of adverse events
- Is there a change in gut microbiota driven by per oral methotrexate that is different from the change driven by subcutaneous methotrexate
- What are the trade-offs newly diagnosed patients with RA willing to make with regard to treatment with methotrexate?
- What are the maximum acceptable levels of risks for newly diagnosed patients with RA?
- Is there a difference in health-related quality of life in patients treated with per oral methotrexate compared to patients treated with subcutaneous methotrexate during the first two years of treatment?
- Is it possible to further model a difference in health-related quality of life during further follow up of these individuals?
Conditions and MedDRA coding
Rheumatoid arthritis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- The subject has given written consent to participate in the study
- Diagnosis of rheumatoid arthritis by rheumatologist fulfilling 2010 Rheumatoid Arthritis Classification Criteria
- Indication of methotrexate
- 18-95 years of age
- Women of Childbearing Capacity (WOCBC) must: a) Comply to use of highly effective contraception methods during the course of the trial. b) Have a negative pregnancy test.
- Male patients included in the study that have fertile female partners must use adequate contraception within their relationship during the same period of time
Exclusion criteria 8
- Contraindications for methotrexate
- Previous treatment with any DMARD within the last five years
- Known or suspected allergies against methotrexate or any other substance in the given medication
- Anamnestic information on pregnancy, breastfeeding, or planned pregnancy
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation or inability to answer questionnaire in written Swedish
- Treatment or disease which, according to the investigator, can affect treatment or study results.
- Fear of needles leading to not being able to use subcutaneous injections
- For the study in gut microbiota: Use of antibiotics or probiotics within the last 3 months
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- DAS28
Secondary endpoints 17
- Number of swollen joints
- Number of tender joints
- HAQ
- VAS pain
- VAS general health
- VAS fatigue
- Doctor's global assessment
- Number of individuals remaining on the designated drug (drug retention) including number of individuals prescribed biologic treatment
- Number of patient´s contact with any health care giver
- All other medications, including corticosteroids, other csDMARDs, biologics, intraarticular injections as well as change in dosage or administration route of methotrexate
- ESR
- CRP
- Number of AE
- Patients preferences
- EQ5D
- Gutmicrobiota
- Questions on diet and alcohol consumption
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB08856MIG · Substance
- Active substance
- Methotrexate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 3120 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08856MIG · Substance
- Active substance
- Methotrexate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 3120 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Vaesterbotten
- Sponsor organisation
- Region Vaesterbotten
- Address
- Daniel Naezéns Väg, Alidhem Alidhem
- City
- Umeå
- Postcode
- 907 37
- Country
- Sweden
Scientific contact point
- Organisation
- Region Vaesterbotten
- Contact name
- Anna Södergren
Public contact point
- Organisation
- Region Vaesterbotten
- Contact name
- Anna Södergren
Locations
1 EU/EEA country · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruitment ended | 212 | 9 |
| Rest of world | — | 0 | — |
Investigational sites
Region Dalarna
Reumatolgiska kliniken, Vasagatan 27, Falu Kristine, Falun
Region Gaevleborg
Reumatologisk klinik, Gävle sjukhus, Rektorsgatan 1, 802 50, Gavle
Region Vaesterbotten
Reumatologiska kliniken, Koksvagen 11, Alidhem, Umea
Skaraborg Hospital-Vastra Gotalandsregionen
Reumatologmottagningen, Lovangsvagen 1, 541 42, Skovde
Region Vaestmanland
Reumatologisk klinik, Västerås sjukhus, Sigtunagatan, 721 89, Vasteras
Malarsjukhuset Eskilstuna
Reumatolgisk klinik, Region Sörmland, Kungsvagen 42, Tunafors, Eskilstuna
Region Stockholm – SLSO
Centrum för reumatologi, Solnavagen 1 E, S:t Matteus, Stockholm
Region Vaesternorrland
Reumatologisk klinik, Lasarettsvagen 21, 856 43, Sundsvall
Region Oerebro Laen
Reumatologsektionen, Sodra Grev Rosengatan, 701 85, Orebro
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2022-04-28 | 2022-04-28 | 2024-12-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements (for publication) | Plain document_MTXRA 2024-512453-25-00 | 1 |
| Subject information and informed consent form (for publication) | Forskningspersonsinformation MTXRA | 1.1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-03 | Sweden | Acceptable 2024-07-02
|
2024-07-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-03 | Sweden | Acceptable | 2025-03-17 |