Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Intervention1: Tab. Metformin 500 mg: TAblet MEtformin 500 mg BD orally
Control Intervention1: PLacebo: Placebo tablet (Calcium 500mg)
Sponsors
D. Y. Patil Deemed to be University School of Medicine, Navi-Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients older than 18 years (of both sexes) diagnosed with rheumatoid arthritis according to ACR or EULAR 2010 criteria. 2. Patients received the standard therapy (i.e., one or more conventional DMARDs) for at least three months 3. Diagnosed cases of Rheumatoid arthritis (Rheumatoid Arthritis factor positive). 4. Onset of symptom duration greater than or equal to 6 months at the time of screening 5. Greater than or equal to 5 score on 10-point visual analogue scale (VAS) for pain at baseline. 6. Willing to give consent for participating in the study.
Exclusion criteria
Exclusion criteria: 1. Patients having severe disabling arthritis in the targeted or contralateral joint. 2. Patients with radiologically abnormal knee alignment. 3. Patients with a history of Chikungunya, Dengue, or other viral infections in the past six months. 4. Participants with a history or presence of Type 1 and Type 2 diabetes. 5. Those who are on treatment with immunosuppressive drugs and biologicals 6. Participants who are taking any other oral hypoglycaemic drugs. 7. Participants who are taking metformin for any other indication. 8.Participants who are prone to gastrointestinal symptoms like nausea, vomiting, diarrhoea, flatulence, and Vitamin B12 deficiency. 9. Pregnant and lactating women. 10. Any condition which, in the opinion of the investigator, will place the subject at risk or will influence the conduct of the study or interpretation of results. 11. Diagnosed cases of Gouty arthritis (Serum Uric acid greater than UNL). 12. Patient requiring any systemic analgesic for other conditions that can affect the outcome of the study drug. 13. Patient on systemic corticosteroid therapy. 14. Known case of history of allergy with NSAIDs or test drug. 15. Patients with a BMI greater than or equal to 40 kg/m2 16. Participants who have enrolled in any other trial in the past 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change from baseline in Disease Activity Score-28 (DAS-28) for severity of RA at weeks 1, week 2, week 3 and week 4Timepoint: 1.Change from baseline in Disease Activity Score-28 (DAS-28) for severity of RA at weeks 1, week 2, week 3 and week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in PGHA domain score for pain of affected joint at weeks 1, 2, week 3 and week 4 2. Change from baseline in the Fatigue Severity Scale (FSS) for pain at weeks 1, week 2, week 3 and week 4 3. Change from baseline in Clinical Disease Activity Index (CDAI) scores assessed at weeks 1, week 2, week 3 and week 4 4. Change from baseline in Simplified Disease Activity Index (SDAI) scores assessed at weeks 1, week 2, week 3 and week 4 5. Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) scores assessed at weeks 1, week 2, week 3 and week 4 6. Need for rescue analgesics at weeks 1, week 2, week 3 and week 4 7. Incidence of clinical adverse events (AEs), treatment emergent adverse events (TEAEs), and serious adverse events (SAEs) Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDr Adwait Malik
DY Patil deemed to be University School of Medicine, Navi Mumbai
Outcome results
None listed