Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Intervention1: Methotrexate and Tofacitinib: Oral Tablet Methotrexate dose 25mg once weekly or maximum tolerated dose once weekly with oral Tablet Tofacitinib 5mg twice daily dose upto 16 weeks
Contro
Sponsors
Indian Rheumatology Association
Eligibility
Inclusion criteria
Inclusion criteria: satisfying presence of classification criteria ACR/EULAR rheumatoid arthritis classification criteria 2010, has suboptimal response to maximal tolerated dose or 25mg stable dose for at least 6 weeks to methotrexate monotherapy defined by Disease Activity Score DAS 28 CRP >3.2 at 3 months.
Exclusion criteria
Exclusion criteria: 1 Blood dyscrasias at screening 2 Absolute white blood cell count (WBC) 3 Absolute neutrophil count (ANC) 4 Absolute lymphocyte count 5 Platelet count 6 Estimated Creatinine Clearance 7 Total bilirubin, AST or ALT more than 2 times the upper limit of normal (ULN) at screening 8 Patients having active tuberculosis or positive for latent tuberculosis as tested by QuantiFERON-TB Gold In Tube (QFT Gold test) or Montoux skin Test. • History of recurrent herpes zoster or herpes simplex. • History of lymphoproliferative disorder. • Present malignancy or with a history of malignancy • Pregnant female or breast feeding mothers. • History of Sulfa drug allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the response by ACR 20 responseTimepoint: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of ACR 50/70 response Assessment of EULAR response by DAS 28-CRP Assessment of HAQ Assessment of IL 6 LEVELS Side effects profile of individual Combination therapy of methotrexate & Leflunomide, methotrexate & sulfasalazine, methotrexate & Tofacitinib. Timepoint: week 16 | — |
Countries
India
Contacts
Public ContactDr Ashlesha Shukla
IMS AND SUM HOSPITAL
Outcome results
None listed