Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis

Sponsor
Dr. Mohammad Mamun Khan
Study ID
NCT04464642
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methotrexate — DRUG
    Methotrexate 25 mg subcutaneous is given in group A
  • Tofacitinib — DRUG
    tofacitinib 10 mg given in group B

Study Details

It is a randomized controlled study

Key Dates

Start date
Jul 10, 2019
Status verified
Jul 2020
Primary completion
Aug 31, 2020
Completion
Sep 30, 2020

Study Design

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

Arms

  • Experimental: group A
    group "A" is a control arm who will get conventional drug (methotrexate). 25 mg subcutaneous weekly . at 3 months if DAS-28 not fall by at least 1.2, drug is to be changed and regarded as therapy failure. if at least 1.2 improvement of DAS-28 occur,then therapy is continued for 6 monyhs
  • Experimental: group B
    group "B" will get tofacitinib 10 mg weekly. if DAS-28 not improved at least 1.2 at 3 months, it is regarded as therapy failure. if improved at least 1.2, then therapy continued for 6 months

Primary Outcome Measure

DAS-28 CRP at 6 month [ Time Frame: 6 months ]

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