Baricitinib, Methotrexate as Monotherapy or Combination in the Treatment of Rheumatoid Arthritis - an Open Label Randomized Clinical Trial

Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study ID
NCT05827497
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Baricitinib 2 MG — DRUG
    baricitinib 2 mg once daily
  • Methotrexate 25mg — DRUG
    25mg daily

Study Details

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

Key Dates

Start date
Apr 1, 2023
Status verified
Apr 2023
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    baricitinib 2 mg once daily
  • Active Comparator: Group B
    methotrexate on 25 mg weekly

Primary Outcome Measure

DAS 28 ESR [ Time Frame: 24 weeks ]

Central Contacts

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