A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis

Not Applicable

• Conditions: -M069; M069

• Registration Number: PER-071-05
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-05
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1140/5000
1. Able and willing to give written, free and informed consent and comply with the requirements of the study protocol.
2. Patients with Rheumatoid Arthritis diagnosed of> 3 months duration.
3. Receiving treatment as an outpatient.
4. Prior to randomization, etamecept should be discontinued for> 2 weeks, infliximab or adalimumab for> 8 weeks, anakinra for> 1 week, leflunomide for> 12 weeks.
5. All DMARDs withdrawn before the baseline.
6. Inflamed joint count (SJC)> 6 and painful joint count (TJC)> 8.
7. During PCR selection> 1 mg / dL (10 mg / L) or ESR> 28 mm / h.
8. Age> 18 years.
9. Oral corticosteroids and NSAIDs are allowed if the dose has been stable for at least 6 weeks before.
10. Women with gestational capacity and men with female partners with gestational ability can participate in this trial only if they are using a reliable means of contraception.
11. If she is a woman and capable of gestation, the patient must have a pregnancy test in negative urine within three weeks before the baseline.

Exclusion Criteria

1. Major surgery within prior eight weeks.
2. Rheumatic autoimmune disease apart from AR.
3. Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis.
4. Previous or current history of joint inflammatory disease apart from RA.
5. Treatment with MTX within 6 months prior.
6. Previous discontinued MTX treatment as a result of clinically significant toxic effects or lack of response.
7. Unsuccessful treatment with an anti-TNF agent.
8. Treatment with any research agent within four weeks of the selection.
9. Previous treatment with any cell depletion therapy.
10. Treatment with intravenous globulin, plasmapheresis or Prosorba ™ column within six months of the baseline.
11. Intra-articular or parenteral corticosteroids within six weeks before the baseline.
12. Immunization with live / attenuated virus vaccines within four weeks before the baseline.
13. Previous treatment with MRA.
14. Any previous treatment with alkylating agents.
15. History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.
16. Evidence of cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal concomitant
17. States of uncontrolled disease.
18. Current liver disease.
19. Currently active or recurrent historical infections.
20. Primary or secondary immunodeficiency.
21. History of malignancy, including solid tumors and hematologic malignancies.
22. Pregnant women or nursing mothers.
23. History of alcohol, drug or chemical abuse within six months before the selection.
24. Neuropathies or other painful conditions.
25. Patients with lack of peripheral venous access.
26. Body weight of> 150 Kg.
27. Serum creatinine> 1.4 mg / dL in female patients and> 1.6 mg / dL in male patients.
28. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 1.5 times the upper limit of normal (ULN).
29. Platelet count <100,000 / mm3.
30. Hemoglobin <8.5 g / dL.
31. Leukocytes <3000 / mm3.
32. Absolute Neutrophil Count <2000 / mm3.
34. Lymphocyte Absolute Count <500 / mm3.
35. HBsAg Positive, or Hepatitis C antibody.
36. Total Bilirubin> ULN.
37. Triglycerides> 10 nunol / L (> 900 mg / dL).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical evaluation: Improvement in at least 20% in the counting of painful and inflamed joints.<br><br>Measure:Primary efficacy: Proportion of patients with an ACR20 response.<br>Timepoints:Week 24.<br>;<br>Outcome name:Panel of hematology and serum biochemistry.<br>Lipid panel.<br>Urinalysis<br>Hemolysis profile.<br>Liver Function Profile.<br>Measure:Alterations in laboratory tests.<br>Timepoints:Panel of hematology and serum biochemistry: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32.<br>Lipid panel: Weeks 0, 6, 14, 24, 28, 32.<br>Urinalysis: Weeks 0, 4, 8, 16, 24, 28, 32.<br>Hemolysis profile: Weeks 0, 24, 28, 32.<br>Hepatic Function Profile: Week 0.<br>