A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00502996
• Date of registration: 17/07/2007
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.
• Scientific title: Multicenter Non-Comparative Expanded Access Program of to Assess Safety of Rituximab (Mab Anti Cd-20) in Patients With Rheumatoid Arthritis (Ser)
• Date of first enrolment: February 2006
• Target sample size: 246
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00502996
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, Chile, Colombia, Ecuador, El Salvador, Mexico, Peru, Uruguay, Venezuela

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- adult patients, >=18 years of age;

- rheumatoid arthritis >=6 months;

- lack of response to 1-5 DMARDs or biological agents;

- rheumatoid factor positive.

Exclusion Criteria:

- other chronic inflammatory articular disease or systemic rheumatic disease;

- joint or bone surgery during 8 weeks prior to randomization;

- previous treatment with any cell-depleting therapy.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Methotrexate

Drug: rituximab [MabThera/Rituxan]

Primary Outcome(s)

Number of Participants With AEs of Special Interest During the Study [Time Frame: Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)]

Number of Participants With Any Adverse Event, Any Serious Adverse Event, and Death [Time Frame: Up to Week 48]

Number of Participants With AEs According to Degree of Intensity [Time Frame: Up to Week 48]

Number of Participants With AEs Leading to Discontinuation and Any Drug Related AEs and SAEs [Time Frame: Up to Week 48]

Secondary Outcome(s)

Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit [Time Frame: Screening (Days -28 to 0) and EOT (Week 24)]

Mean Values of Biochemistry Parameters at Screening and Visit 8 (Albumin and Glucose) [Time Frame: Screening (Days -28 to 0) and EOT (Week 24)]

Mean Values of Hematology Parameters at Screening and EOT Visit (Leucocytes and Platelets) [Time Frame: Screening (Days -28 to 0) and EOT (Week 24)]

Mean Value of Painful Joints [Time Frame: Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)]

Mean Values of C Reactive Protein [Time Frame: Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48)]

Mean Duration of Morning Joint Stiffness [Time Frame: Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48)]

Mean Value of Quality of Life (Health Assessment Questionnaire - Disease Index) [Time Frame: Screening (Days -28 to 0), Week 1, Week 12, and Week 24]

Mean Values of Globular Sedimentation Velocity [Time Frame: Screening ((Days -28 to 0), Week 1, Week 12, and Week 24]

Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils) [Time Frame: Screening (Days -28 to 0) and EOT (Week 24)]

Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit. [Time Frame: Screening (Days -28 to 0) and EOT (Week 24)]

Mean Values of Hematology Parameter at Screening and EOT Visit (Mean Corpuscular Volume) [Time Frame: Screening (Days -28 to 0) and EOT (Week 24)]

Mean Values of Hematology Parameters at Screening and EOT Visit (Hemoglobin and Mean Corpuscular Hemoglobin Concentration) [Time Frame: Screening (Days -28 to 0) and EOT (Week 24)]

Mean Values of Pain and Activity Based on Visual Analogue Scale [Time Frame: Screening ((Days -28 to 0), Week 1, Week 12, and Week 24]

Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit [Time Frame: Screening (Days -28 to 0) and EOT (Week 24)]

Mean Value of Inflamed Joints [Time Frame: Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)]

Mean Values of Hematology Parameter at Screening and EOT Visit (Erythrocytes) [Time Frame: Screening (Days -28 to 0) and EOT (Week 24)]

Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria [Time Frame: Week 1, Week 12, and Week 24]

Secondary ID(s)

ML19385

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/10/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00502996