An Observational Study of Rituximab in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis

NCT01283399 | Completed

• 1 other identifier: ML25270
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 5

Brief Summary

This observational study will assess the efficacy and safety of combination of rituximab (MabThera) and methotrexate in participants with active refractory rheumatoid arthritis (RA) who have failed to respond to a single course of anti-tumor necrosis factor (TNF) therapy in routine clinical practice. Data will be collected from participants for 12 months after the first dose of rituximab or a minimum of 6 months following a rituximab re-treatment course.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Disease Activity Score Based on 28-joints Count (DAS28)

  Up to 5 years

Secondary Outcomes (4)

• Reasons for Re-treatment With Rituximab Within 6 Months of the First Treatment

  Up to 5 years

• Disease Activity Score Based on 28-joints Count (DAS28) 6 Months After the Re-treatment With Rituximab

  6 Months After the Re-treatment With Rituximab (up to 5 years)

• Demographics of Participants Eligible to Receive Rituximab

  Baseline

• Number of Participants With Adverse Events

  5 years

Study Arms (1)

Rituximab + Methotrexate

All participants with active refractory RA who were eligible to receive treatment with methotrexate and rituximab in the Investigators' opinion as per the routine clinical practice following inadequate response to a single cycle of anti-TNF therapy.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All participants with active refractory RA who were eligible to receive treatment with methotrexate and rituximab in the Investigators' opinion as per the routine clinical practice following inadequate response to a single cycle of anti-TNF therapy.

You may qualify if:

• Active rheumatoid arthritis
• Inadequate response to a single TNF inhibitor
• Participants receiving rituximab therapy in accordance with the prescribing information
• Signed data release form within 6 weeks (42 days) of initiating rituximab therapy
• Women of childbearing potential must use effective form of contraception

You may not qualify if:

• Contra-indication to receive rituximab according to the local labelling
• Previous treatment with rituximab
• Treatment with any investigational drug within 30 days prior to enrolment

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (5)

Unknown Facility

Beirut, 11-236, Lebanon

Location

Unknown Facility

Beirut, 99999, Lebanon

Location

Unknown Facility

Beirut, Lebanon

Location

Unknown Facility

Byblos, 1401, Lebanon

Location

Unknown Facility

Tripoli, 371 Tripoli, Lebanon

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 26, 2011
• Study Start: August 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

LE (5)