Filgotinib bridging in newly diagnosed rheumatoid arthritis patients (FAST RA trial); A pragmatic randomized controlled non-inferiority low intervention clinical trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medisch Spectrum Twente

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Decision date (initial)

2025-01-16

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Own resources of the Rheumatology department of Medisch Spectrum Twente hospital

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To investigate non-inferiority and potential superiority in achieving disease activity remission at 3 months of bridging with a JAK inhibitor (Filgotinib 200 mg once daily for 3 months) versus bridging with corticosteroids (triamcinolone 120 mg single dose im) when starting with methotrexate and hydroxychloroquine therapy in rheumatoid arthritis patients.

Secondary objectives 9

1. To compare changes in disease activity scores over 12 months of treatment between the two bridging treatment strategies.
2. To compare changes in relevant biomarkers (CRP, ESR, cytokine levels) during 12 months of treatment.
3. To compare patient-reported outcomes between both bridging treatment strategies over 3 months.
4. To compare time to achievement of disease activity remission between the two bridging strategies.
5. To compare the duration of remission achieved in each treatment arm after discontinuation of the bridging therapy.
6. To assess the adherence to treatment in both treatment arms.
7. To assess patient satisfaction with both treatment strategies.
8. To evaluate and compare incidence and severity of adverse drug effects between both bridging strategies.
9. To compare cost-effectiveness of both bridging strategies.

Conditions and MedDRA coding

Rheumatoid arthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Newly diagnosed rheumatoid arthritis patients according to a rheumatologist
2. DMARD-naive
3. Age 18 – 64 years old
4. DAS28-CRP > 2.6 at the start of the study
5. Dutch proficiency
6. Signed informed consent

Exclusion criteria 6

1. Current or prior treatment with DMARDs
2. Risk of cardiovascular diseases
3. Risk of malignancies, including current smoking of having smoked for a long time
4. (Planned) pregnancy or planning to father a child
5. Contra-indications for methotrexate, adalimumab, tocilizumab, hydroxychloroquine, triamcinolone, filgotinib or folic acid (protocol section 4.3)
6. Corticosteroid use in the last three months

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of this study is the percentage of rheumatoid arthritis patients in remission (DAS28-CRP < 2,6) at three months.

Secondary endpoints 11

1. Disease activity remission at 6, 9 and 12 months
2. Disease activity scores and components at 3, 6, 9, and 12 months
3. Changes in biomarkers: CRP and ESR
4. Time to diseases activity remission and remission duration
5. Patient-reported outcome measures
6. Adherence to treatment
7. Patient satisfaction
8. Adverse events: incidence and severity (side effects)
9. Direct and indirect costs
10. The cumulative dosage of corticosteroids over the study period
11. The cumulative usage of bDMARDs over the study period

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medisch Spectrum Twente

Sponsor organisation

Medisch Spectrum Twente

Address

Koningsplein 1

City

Enschede

Postcode

7512 KZ

Country

Netherlands

Scientific contact point

Organisation

Medisch Spectrum Twente

Contact name

Research Reumatologie

Public contact point

Organisation

Medisch Spectrum Twente

Contact name

Research Reumatologie

Locations

1 EU/EEA country · 1 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 6 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