A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.
- Conditions
- -M069M069
- Registration Number
- PER-082-05
- Lead Sponsor
- PRODUCTOS ROCHE Q.F.S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. Be able and willing to provide written informed consent and meet the requirements of the study.
2. Patients with Rheumatoid Arthritis diagnosed at least 6 months before.
3. Be under treatment in outpatient clinic.
4. Failure to treat with at least one but no more than five DMARDs or biological medications.
5. Have received methotrexate at a dose of 10-25 mg / week for at least 12 weeks, with a stable dose during the 4 weeks prior to screening.
6. Suspend all DMARDs other than methotrexate at least 4 weeks before randomization (8 weeks for infliximab, adalimumab, etanercept, and leflunomide).
7. Have Inflated Joint Count> 8 and Painful Joint Count> 8 during the count.
8. During the count, have: C-reactive protein> 1.5 mg / dl (15 mg / l) or Globular Sedimentation Rate> 28 mm / hr.
9. Age between 18-80 years.
10. The use of non-steroidal anti-inflammatory drugs is allowed if your dose has been stable for at least 2 weeks prior to screening.
11. If the patient has reproductive potential, he should use adequate contraceptive methods.
12. Women of reproductive age should have a negative pregnancy test in urine during the 2 weeks prior to inclusion in the study.
13. Positive rheumatoid factor.
1. Bone / joint surgery during the 8 weeks prior to scrutiny or joint surgery planned during the 24 weeks prior to inclusion.
2. Rheumatoid autoimmune disease other than Rheumatoid Arthritis or significant generalized disease secondary to Rheumatoid Arthritis.
3. Functional class IV defined based on the Rheumatoid Arthritis functionality criteria of the ACR.
4. History or current manifestation of inflammatory joint disease other than Rheumatoid Arthritis or other generalized rheumatic disease.
5. Concomitant treatment with any DMARD (except methotrexate) or therapy with any anti-TNF or other biological therapy.
6. Treatment with any investigational medication during the previous 3 months.
7. Previous treatment with therapies that decrease the number of cells.
8. Treatment with y-globulin IV or with Prosorba® column during the previous 6 months.
9. Intra-articular or parenteral corticosteroids during the 4 weeks prior to inclusion.
10. Administration of a vaccine with live agents during the 4 weeks prior to the start of the study.
11. Previous treatment with Rituximab (MabThera®).
12. History of severe allergy or anaphylactic reactions induced by monoclonal antibodies humanized or of murine origin.
13. Significant cardiac or pulmonary disease.
14. Evidence of significant uncontrollable concomitant disease.
15. Active viral, mycotic, bacterial, mycobacterial or other infection or any episode of infection that has required hospitalization or IV treatment with antibiotics during the 4 weeks prior to the scrutiny or oral antibiotics during the 2 weeks prior to the scrutiny.
16. History of significant recurrent infection or history of recurrent bacterial infections.
17. History or presence of primary or secondary immunodeficiency
18. History of cancer, including solid tumors and hematologic disease.
19. Pregnant or lactating women.
20. History of alcohol, drugs or drug abuse during the 6 months prior to the count.
21. Neuropathies and neurovascular diseases that could interfere with the assessment of pain.
22. Inaccessible peripheral veins.
23. Intolerance or contraindications to corticosteroids IV
24. Serum creatinine> 1.4 mg / dL for women or 1.6 mg / dL for men.
25. Aspartate aminotransferase or alanine aminotransferase> 2.5 x ULN.
26. Platelets <100,000 / uL.
27. Hemoglobin <8.5 g / dL.
28. Neutropenia <1.5 x 10 3 / uL.
29. Positive serological diagnosis of hepatitis B or C.
30. HIV positive.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Clinical evaluation: A guided rheumatological evaluation, evaluation of changes in vital signs, and the appearance of adverse events will be carried out.<br><br>Measure:Safety of the treatment.<br>Timepoints:Before starting the treatment and in weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Hematological panel: Hb, Hct, erythrocytes, leukocytes, absolute count, differential and platelets.<br>Panel of serum chemistry: AST, ALT, alkaline phosphatase, total proteins, albumin, cholesterol, total bilirubin, urea, uric acid, creatinine, glucose, lactic dehydrogenase, potassium, sodium, chlorine, calcium, phosphorus.<br>Urinalysis: detection of blood, proteins and glucose (microscopic examination in case abnormalities are found and where appropriate).<br>Rheumatoid Factor, Globular Sedimentation Rate and C Reactive Protein.<br>Measure:Abnormalities in laboratory tests.<br>Timepoints:Hematological and chemical panels, urinalysis, liver panel: Before starting treatment and in weeks 1, 2 12, 24.<br>Rheumatoid Factor, Globular Sedimentation Rate and C Reactive Protein: Before starting treatment and at weeks 1, 12 and 24.<br>