A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis (IMAGE)
- Conditions
- -M069M069
- Registration Number
- PER-007-07
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 35
1. Be willing to grant written informed consent and comply with the requirements of the study protocol.
2. Patients with active rheumatoid arthritis diagnosed for at least 8 weeks but not more than 4 years.
3. Virgin patients to, and considered to be candidates for, treatment with methotrexate.
4. Swollen joint count (SJC) ≥ 8, and Painful joint count (TJC) ≥ 8.
5. CRP ≥12 mg / dL.
6. From 18 to 80 years of age.
7. Glucocorticoids ≤ 10 mg / day of prednisolone or equivalent allowed if it is stable at least 4 weeks before the baseline visit.
8. The use of NSAIDs is allowed if it is stable for at least 2 weeks before the baseline visit.
9. For patients of reproductive age (men and women), use reliable contraceptive methods throughout their participation in the study.
10. They must agree to receive oral folate.
11. Only for RF negative patients: Radiographic evidence of at least one joint with erosion attributable to rheumatoid arthritis (RA).
12. Patients who are going to receive or who are currently receiving, treatment for RA as outpatients.
1. Autoimmune rheumatic disease different from RA, or with significant systemic manifestations.
2. Functional class IV.
3. History of inflammatory joint disease different from RA.
4. Diagnosis of juvenile idiopathic arthritis before the age of 16 years.
5. Any surgical procedure.
6. Lack of peripheral venous access.
7. Pregnancy or breastfeeding, maternal.
8. Significant pulmonary or cardiac disease.
9. Evidence of significant uncontrolled concomitant disease.
10. Primary or secondary immunodeficiency.
11. Known active infection of any kind, or any significant episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to the baseline visit or the termination of oral antibiotics within 2 weeks before the baseline visit.
12. History of deep tissue / space infections within 52 weeks before the baseline visit.
13. History of severe chronic or recurrent infection.
14. History of cancers.
15. Any vascular or systemic neurological disorder that could affect any of the efficacy evaluations.
16 Current alcoholism or drug addiction or history of drug addiction or alcoholism in the 24 weeks prior to the initial visit.
17. History of severe anaphylactic or allergic reaction to a biological agent or known hypersensitivity to any component of rituximab or to human proteins.
18. Pre-treatment with any biological agent under investigation or approved for RA.
19. Pre-treatment with an anti-alpha4 integrin antibody or costimulation modulator.
20 Concomitant treatment with a biological agent other than MTX.
21 Pre-treatment with any therapy to reduce cells.
22 Treatment with any agent under investigation within 28 days of the baseline visit or 5 half lives of the investigational medication.
23. The reception of any vaccine within 28 days prior to the baseline visit.
24. Parenteral or intra-articular glucocorticoids within the 4 weeks prior to the baseline visit.
25. Intolerance or contraindications to glucocorticoids IV.
26. Positive human chorionic gonadotropin.
27. Positive tests for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or serology for hepatitis C.
28. Hemoglobin <8.0 g dL.
29- Serum IgG and / or IgM concentrations below 5.0 and 0.40 mg / mL.
30. Absolute neutrophil count <1.5 x 10-3 / uL.
31. ALT or AST> 2.5 times the normal upper limit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Separate radiographs of each posteroanterior (AP) hand and each anterior anteroposterior (AP) foot. These images will be evaluated by the modified Sharp-Genant scale, which evaluates erosion and shortening of the joint space of both feet and hands.<br>Measure:Change in the modified Sharp total scale.<br>Timepoints:Week 52.<br>
- Secondary Outcome Measures
Name Time Method