Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Intervention1: Tofacitinib: Oral tofacitinib 5 mg twice daily for 8 weeks
Control Intervention1: Oral prednisolone: Oral prednisolone in a predetermined tapering regimen [10 mg once daily (week 1-2),
Sponsors
Post Graduate Institute of Medical Education and Research Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria are those diagnosed with RA fulfilling the ACR/EULAR 2010 criteria, with disease duration less than 5 years, age between 18 and 60 years and active disease which is defined at least 10 tender joints and at least 4 swollen joints (substantial disease activity) and pain NRS more than 6 out of 10
Exclusion criteria
Exclusion criteria: Exclusion criteria include those who have received methotrexate, leflunomide or sulfasalazine in last 3 months, JAKi or steroids in last 4 weeks, known methotrexate intolerance, haemoglobin under 7 grams per dl, leukopenia under 4000 per cu mm, thrombocytopenia under 1,00,000 per cu mm, serum creatinine 1.3 mg/dl or higher, total bilirubin, AST or ALT more than 1.5 times the upper limit of normal, positive hepatitis B or C or HIV, known case of chronic liver disease or chronic lung disease like bronchiectasis or ILD with FVC less than 70 percent, those pregnant or lactating or desirous of pregnancy in the next 6 months, active tuberculosis or other active infection, current or past smokers, malignancy or history of malignancy, with the exception of adequately treated or excised non-metastatic basal-cell or squamous cell cancer of the skin or cervical carcinoma in situ, history of myocardial infarction, heart failure, blood clots, undergoing major surgery or immobilized, taking combined hormonal oral contraceptive pills or hormone replacement therapy, uncontrolled diabetes mellitus (HbA1c more than 7.5 percent) or hypertension (SBP more than 160 mm Hg, diastolic BP more than 100 mm Hg or requiring 2 or more antihypertensives), glaucoma, complicated gastric or duodenal ulcer, recent fracture in the last 3 months, any other contraindication as per treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delta DAS28-CRPTimepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Delta DAS28-CRPTimepoint: 4 and 16 weeks;ACR 20, 50, 70Timepoint: 4, 8 and 16 weeks;Remission or low disease activity as per CDAI and SDAITimepoint: 8 and 16 weeks;Delta IHAQTimepoint: 8 and 16 weeks;Compare proportion with DAS28 less than 3.2Timepoint: 16 weeks;All adverse events including laboratory abnormalitiesTimepoint: At each time point;Serious adverse eventsTimepoint: At each time point;Adverse effects of special concern: Glucocorticoids- weight gain, hypertension (new diagnosis or worsening of pre-existing hypertension), cushingoid, acne, infections; Tofacitinib- deep vein thrombosis, myocardial infarction, pulmonary thromboembolism, stroke, infections, herpes zoster, malignancy Timepoint: At each time point | — |
Countries
India
Contacts
Public ContactVarun Dhir
Post Graduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed