Rheumatoid Arthritis
Conditions
Keywords
Pakistan, Rituximab, RA
Brief summary
A study to determine the efficacy and safety of rituximab in Pakistani patients with rheumatoid arthritis (RA) who have been inadequately controlled with standard disease modifying anti rheumatic drugs (DMARDs).
Detailed description
Enrolled subjects with inadequately-controlled RA had their disease activity level assessed before initiation of therapy and at intervals of 6 months and 12 months thereafter. Standardized disease activity scores like the Disease Activity Score-28 (DAS 28) were used for determining remission or otherwise of the disease. The American College of Rheumatology (ACR) 20, 50 and 70 response scores and the European League of Associations for Rheumatology (EULAR) Response Criteria for RA were used to determine the percentage improvement in the individual subject's condition at the same intervals. The former utilizes a set of assessments to determine if, after a given therapy, there has been a 20, 50 or 70% improvement in the aggregate scores as compared to the baseline and the latter utilizes calculated improvements in the DAS 28 score to determine if the response to treatment has been good, moderate or none. Both of these have been validated and approved for use by the ACR and EULAR respectively. The study enrollment period was from 1st January 2010 till 31st December 2010. Observation period was 12 months from the enrollment date for each subject. The final results are being reported here.
Interventions
DRUGRituximab
Rituximab was administered as an intravenous infusion as per approved protocol on Day 1 and day 14. The protocol stipulated the administration of intravenous hydrocortisone 100 mg and oral pheniramine maleate 43.5 mg as pre-medication. The Rituximab itself was given as a 1 gm infusion slowly over a period of 4-6 hours. This was done either by a specialist nurse or a trained doctor.
Sponsors
Aga Khan University
Fatima Memorial Hospital
Fauji Foundation Hospital
Prof. Abid Z. Farooqi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Able and willing to give written informed consent. 2. Men and women aged 18-80 years, inclusive. 3. Patients with RA for at least 6 months. 4. DAS28 score \> 3.70 at baseline. 5. Inadequate response to methotrexate (MTX), for at least 4 weeks using a stable dose of 15mg/week. Glucocorticoids (\<10 mg/day prednisone or equivalent) permitted if stable for at least 4 weeks prior to baseline. 6. Use of Non-steroidal anti-inflammatory drugs (NSAIDs) permitted if stable dose for at least 2 weeks prior to baseline. 7. Patients of reproductive potential (males and females) must be willing to use a reliable method of contraception (e.g. contraceptive pill, intrauterine device (IUD) or a physical barrier) during the study and for 12 months after last Rituximab administration. 8. If female and of childbearing potential, a negative serum pregnancy test within 2 weeks prior to baseline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Disease Activity Assessment Score (DAS-28) | 6 months | To determine the percentage of previously inadequately-controlled RA patients achieving improvement in their disease activity level post treatment with Rituximab at 6 months interval using Disease Activity Score in 28 selected joints (DAS-28). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Status of disease activity level using DAS 28 score | 12 months | To determine the percentage of such RA patients achieving improvement in their disease activity level post treatment at 12 months interval using DAS-28. |
| Status of disease response to treatment using the ACR 20/50/70 response criteria | 12 months | Using the ACR 20/50/70 response criteria |
| Status of disease response to treatment using the EULAR response criteria | 12 months | using the EULAR response criteria |
| Documenting serious adverse events during the trial period | 12 months | Any event leading to hospitalization or death during the trial period |
Outcome results
None listed