Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Intervention1: Oral prednisolone: Participants shall be given Oral Prednisolone daily for 12 weeks as per below mentioned schedule-
Prednisone 7.5 mg orally once daily x initial 28 days
Prednisolone
Sponsors
AIIMS RISHIKESH
SELF FUNDED
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged 18 70 years diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria. 2.Active disease defined by a Disease Activity Score-28 , DAS28, of more than 3.2. 3.Disease duration of less than 1 year 4.Willingness to participate and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Those patients already in remission, as per ACR or EULAR provisional definition of remission. 2.Decompensated cardiac failure ,New York Heart Association classification stage III or IV. 3.Platelet count less than 100,000 per microlitre , risk of intramuscular hematoma. 4.Active tuberculosis 5.Congenital or acquired immunodeficiency , including human immunodeficiency virus. 6.Chronic infection or infections requiring antimicrobial therapy within 1 month. 7.Concurrent presence of other autoimmune disorders. 8.Current or past diagnosis of malignancy. 9.Pregnancy 10.Peptic Ulcer Disease. 11.Uncontrolled diabetes. 12.Uncontrolled hypertension. 13.Life expectancy of fewer than 2 years for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the proportion of patients achieving low disease activity, LDA, defined by DAS 28 CRP less than or equal to 3.2 at 12 weeks.Timepoint: All outcomes will be assessed at four time points, at baseline, after four weeks of baseline, after eight weeks of baseline and final assessment will be conducted after twelve weeks of baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving remission defined by DAS 28 CRP less than 2.6 at 12 weeks. Changes in patient-reported outcomes (HAQDI Indian). To determine the frequency of administration of injectable i.v corticosteroid in case of disease flare in both the arms. Timepoint: All outcomes will be assessed at four time points, at baseline, after four weeks of baseline, after eight weeks of baseline and final assessment will be conducted after twelve weeks of baseline. | — |
Countries
India
Contacts
Public ContactDr Venkatesh S Pai
AIIMS, Rishikesh
Outcome results
None listed