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

NCT02731560 | Completed Phase 4

• 1 other identifier: ML25190
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Rheumatoid Arthritis

Keywords

Pakistan, Rituximab; RA

Outcome Measures

Primary Outcomes (1)

• Improvement in Disease Activity Assessment Score (DAS-28)

  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).

  6 months

Secondary Outcomes (4)

• Status of disease activity level using DAS 28 score

  12 months

• Status of disease response to treatment using the ACR 20/50/70 response criteria

  12 months

• Status of disease response to treatment using the EULAR response criteria

  12 months

• Documenting serious adverse events during the trial period

  12 months

Study Arms (1)

Single Arm

OTHER

Treatment with Rituximab in RA patients showing inadequate response to standard DMARDs

Drug: Rituximab

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.

Also known as: RTX

Single Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to give written informed consent.
• Men and women aged 18-80 years, inclusive.
• Patients with RA for at least 6 months.
• DAS28 score \> 3.70 at baseline.
• 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.
• Use of Non-steroidal anti-inflammatory drugs (NSAIDs) permitted if stable dose for at least 2 weeks prior to baseline.
• 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.
• If female and of childbearing potential, a negative serum pregnancy test within 2 weeks prior to baseline.

You may not qualify if:

• Bed bound or wheelchair bound patients.
• Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
• History of severe allergic or anaphylactic reactions to a biologic agent or known hypersensitivity to any component of Rituximab or to murine proteins.
• Previous treatment with any approved or investigational biologic agent for RA.
• Concurrent treatment with any biologic agent for any indication.
• Receipt of any vaccine within 4 weeks prior to baseline (it was recommended that a patient's vaccination record and the need for immunization prior to receiving Rituximab should be carefully investigated).
• Intolerance to or contraindications to drugs required for the treatment of adverse event of Rituximab (e.g., paracetamol, anti-histamines, hydrocortisone, anti-emetics or histamine-receptor 1 (H1) blockers).
• Intra-articular or parenteral glucocorticoids within 4 weeks prior to baseline.
• Any surgical procedure, including bone / joint surgery / synovectomy (including joint fusion or replacement) within 12 weeks prior to baseline or planned within 24 weeks of randomization.
• Evidence of any severe or significant medical condition(s) or disease(s) that, in the view of the investigator, prohibited participation in the study.
• Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine or gastrointestinal disorders which, in the investigator's opinion, would have precluded patient participation.
• Significant cardiac (heart failure of New York Heart Association (NYHA) class IV) or pulmonary disease (including obstructive pulmonary disease).
• Known active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections), or a known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) anti-infectives within 4 weeks prior to baseline or completion of oral anti-infectives within 2 weeks prior to baseline.
• History of serious recurrent or chronic infection. (for screening for a chest infection a chest radiograph will be performed at screening if not performed within 12 weeks prior to screening).
• Primary or secondary immunodeficiency (history of, or currently active), including known history of human immunodeficiency (HIV) infection.

Sponsors & Collaborators

• Prof. Abid Z. Farooqi: lead
• Aga Khan University: collaborator
• Fatima Memorial Hospital: collaborator
• Fauji Foundation Hospital: collaborator

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Abid Z Farooqi, FRCPI

  Pakistan Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Rheumatology

Study Record Dates

• First Submitted: March 6, 2016
• First Posted: April 7, 2016
• Study Start: January 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2012
• Last Updated: April 7, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share