Rituximab (RTX) for Disease Modifying Anti Rheumatic Drug (DMARD) Non-responders in Pakistan: The Pakistan Rituximab Study (PARIS)

Sponsor
Prof. Abid Z. Farooqi
Study ID
NCT02731560
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    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.

Study Details

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).

Key Dates

Start date
Jan 31, 2010
Status verified
Apr 2016
Primary completion
Jul 31, 2011
Completion
Dec 31, 2012

Study Design

Enrollment
74 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Single Arm
    Treatment with Rituximab in RA patients showing inadequate response to standard DMARDs

Primary Outcome Measure

Improvement in Disease Activity Assessment Score (DAS-28) [ Time Frame: 6 months ]

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