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NCT05827497
Baricitinib, Methotrexate as Monotherapy or Combination in the Treatment of Rheumatoid Arthritis - an Open Label Randomized Clinical Trial
Phase 4 trial testing Baricitinib 2 MG in Rheumatoid Arthritis in 132 participants. Status unknown.
31 March 2024
Quick facts
| Lead sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 132 |
| Start date | 1 April 2023 |
| Primary completion | 31 March 2024 |
| Estimated completion | 31 March 2024 |
| Sites | 1 location across Bangladesh |
Drugs / interventions tested
- Baricitinib 2 MG — full drug profile →
- Methotrexate 25mg — full drug profile →
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Who can join
18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this open-label randomized clinical trial is to assess the efficacy of baricitinib 2 mg in comparison to methotrexate 25 mg as monotherapy followed by baricitinib 4 mg in comparison to methotrexate 10 mg and baricitinib 2 mg combination in patients with rheumatoid arthritis with moderate to severe disease activity. The main question it aims to answer: • Is there any difference in the efficacy of baricitinib as monotherapy in comparison to methotrexate monotherapy or methotrexate-baricitinib combination in the treatment of rheumatoid arthritis
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05827497
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Baricitinib 2 MG
Trials testing the same drug.
- NCT05660655 — Efficacy and Safety of Baricitinib for the Treatment of Moderate to Severe Rheumatoid Arthritis · Phase 4 · completed
- NCT05686746 — Use of Baricitenib to Maintain of Remission · Phase 2, PHASE3 · unknown
- NCT04916756 — A Prospective Pilot Study to Explore Efficacy and Safety of Baricitinib in Active Primary Sjogren's Syndrome Patients · Phase 1, PHASE2 · completed
Other recruiting trials for Rheumatoid Arthritis
Currently open trials in the same condition.
- NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
- NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
Other Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh trials
Trials by the same sponsor.
- NCT07507045 — Education-Based Oral Health Promotion Intervention During Pregnancy: Implementation Protocol in Bangladesh · NA · not yet recruiting
- NCT07537634 — Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication · Phase 4 · not yet recruiting
- NCT07161336 — Role of Methotrexate in Ultrasound Proven Synovitis in Primary Knee OA · Phase 2 · recruiting
- NCT06960694 — Effect of L-carnitine on Disease Activity in Patients With Mild to Moderate Knee Osteoarthritis · Phase 2 · completed
- NCT07123922 — Effect of Silymarin as Add on Therapy on Oxidative Stress, Pulmonary Function and Quality of Life in Stable COPD Patient · NA · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05827497 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Last refreshed: 25 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05827497.
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