Clinical trial · Interventional
Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis
NCT01593332CI-TRIAL-00006865completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this project the investigators decide to evaluate the efficacy and safety of half dose mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of rheumatoid arthritis. The investigators choose this drug because the use of anti-TNF drugs limited in the investigators refractory patients as the first line drugs because of its cost.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DMARD Resistant Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Rituximab
- interventionNames
- Drug: Rituximab
- type
- ACTIVE_COMPARATOR
- label
- Methotrexate
- interventionNames
- Drug: Rituximab
Primary outcomes (2)
- measure
- change in 28-joint disease activity index( DAS28)
- timeFrame
- Study duration was 6 months and the subjects were assessed for DAS 28 change at baseline, after 2 , 16 and 24 weeks.
- description
- disease activity score 28 formula which caculates based the number of tenderness and swelling of 28 joints and also ESR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 1987 ACR criteria for classification of RA * Positive for rheumatoid factor(RF) * Active RA despite therapy with conventional for at least 3 months as evidenced by DAS 28 \> 3/2 * Patients with active, resistant RA who didn't receive anti TNF agents. Exclusion Criteria: * Patient with hypogammaglobulinemia * Patient with congestive heart failure (classIV) * Active current bacterial,viral,fungal,myocardial or other infections * Chronic hepatitis B or hepatitis C carriers * History of severe allergic reaction to human,humanized or murine monoclonal antibodies * History of malignancies * Pregnant women or lactating mothers 8) Patients with Chronic renal failure and hepatic disease.
References
Publications (0)
Data not yet available
No reference posted for this study.