Clinical trial NCT00502996: A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.
Official title: Multicenter Non-Comparative Expanded Access Program of to Assess Safety of Rituximab (Mab Anti Cd-20) in Patients With Rheumatoid Arthritis (Ser)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate \>=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Any Adverse Event, Any Serious Adverse Event, and Death
timeFrame: Up to Week 48
measure: Number of Participants With AEs According to Degree of Intensity
timeFrame: Up to Week 48
measure: Number of Participants With AEs Leading to Discontinuation and Any Drug Related AEs and SAEs
timeFrame: Up to Week 48
measure: Number of Participants With AEs of Special Interest During the Study
timeFrame: Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)
Secondary outcomes:
measure: Mean Values of Hematology Parameters at Screening and EOT Visit (Hemoglobin and Mean Corpuscular Hemoglobin Concentration)
timeFrame: Screening (Days -28 to 0) and EOT (Week 24)
measure: Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
timeFrame: Screening (Days -28 to 0) and EOT (Week 24)
measure: Mean Values of Hematology Parameter at Screening and EOT Visit (Mean Corpuscular Volume)
timeFrame: Screening (Days -28 to 0) and EOT (Week 24)
measure: Mean Values of Hematology Parameter at Screening and EOT Visit (Erythrocytes)
timeFrame: Screening (Days -28 to 0) and EOT (Week 24)
measure: Mean Values of Hematology Parameters at Screening and EOT Visit (Leucocytes and Platelets)
timeFrame: Screening (Days -28 to 0) and EOT (Week 24)
measure: Mean Values of Biochemistry Parameters at Screening and Visit 8 (Albumin and Glucose)
timeFrame: Screening (Days -28 to 0) and EOT (Week 24)
measure: Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.
timeFrame: Screening (Days -28 to 0) and EOT (Week 24)
measure: Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit
timeFrame: Screening (Days -28 to 0) and EOT (Week 24)
measure: Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit
timeFrame: Screening (Days -28 to 0) and EOT (Week 24)
measure: Mean Duration of Morning Joint Stiffness
timeFrame: Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48)
measure: Mean Value of Painful Joints
timeFrame: Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)
measure: Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria
timeFrame: Week 1, Week 12, and Week 24
measure: Mean Value of Quality of Life (Health Assessment Questionnaire - Disease Index)
timeFrame: Screening (Days -28 to 0), Week 1, Week 12, and Week 24
measure: Mean Values of C Reactive Protein
timeFrame: Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48)
measure: Mean Values of Globular Sedimentation Velocity
timeFrame: Screening ((Days -28 to 0), Week 1, Week 12, and Week 24
measure: Mean Values of Pain and Activity Based on Visual Analogue Scale
timeFrame: Screening ((Days -28 to 0), Week 1, Week 12, and Week 24
measure: Mean Value of Inflamed Joints
timeFrame: Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Córdoba
country: Argentina
city: San Miguel de Tucuman
country: Argentina
city: Tucuman
country: Argentina
city: Belem
country: Brazil
city: Brasilia
country: Brazil
city: Brasilia
country: Brazil
city: Campinas
country: Brazil
city: Campinas
country: Brazil
city: Curitiba
country: Brazil
city: Florianopolis
country: Brazil
city: Fortaleza
country: Brazil
city: Fortaleza
country: Brazil
city: Goiania
country: Brazil
city: Nova Lima
country: Brazil
city: Porto Alegre
country: Brazil
city: Recife
country: Brazil
city: Ribeirão Preto
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Vitoria
country: Brazil
city: Santiago
country: Chile
city: Barranquilla
country: Colombia
city: Bogota
country: Colombia
city: Cuenca
country: Ecuador
city: Guayaquil
country: Ecuador
city: Quito
country: Ecuador
city: San Salvador
country: El Salvador
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: San Luis Potosi
country: Mexico
city: Jesus Maria
country: Peru
city: Lima
country: Peru
city: San Isidro
country: Peru
city: Montevideo
country: Uruguay
city: Barquisimeto
country: Venezuela
city: Caracas
country: Venezuela
city: Caracas
country: Venezuela
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: