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

NCT02731560 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2016-04-07

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Rituximab

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 & Collaborators

  • Aga Khan University

    collaborator OTHER

  • Fatima Memorial Hospital

    collaborator OTHER

  • Fauji Foundation Hospital

    collaborator OTHER

  • Prof. Abid Z. Farooqi

    lead OTHER_GOV

Principal Investigators

  • Abid Z Farooqi, FRCPI · Pakistan Institute of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-07-31
Completion
2012-12-31

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02731560 on ClinicalTrials.gov