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| Sponsor: | Centocor, Inc. |
|---|---|
| Collaborator: |
Schering-Plough |
| Information provided by: | Centocor, Inc. |
| ClinicalTrials.gov Identifier: | NCT00714493 |
Purpose
The purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanercept or adalimumab in addition to methotrexate.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Biological: Infliximab |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 4, Multicenter, Open-Label, Assessor-Blinded Switch Study of the Efficacy and Safety of Infliximab (REMICADE�) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL�) or Adalimumab (HUMIRA�). |
| Enrollment: | 203 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 001 |
Biological: Infliximab
3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
|
This is a Phase 4, multi center, open-label, assessor blinded, switch study,of infliximab in patients with active rheumatoid arthritis who are receiving methotrexate and are having an inadequate response to their current treatment with etanercept or adalimumab. The last dose of etanercept must have been at least 1 week but not more than 2 weeks prior to the first infliximab study infusion. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to the first infliximab study infusion. The study will be conducted for 30 weeks and will include 200 patients. All eligible patients will receive 3 mg/kg infliximab infusions (drug given into a vein) at weeks 0, 2, and 6 and every 8 weeks thereafter, if they achieve a European League Against Rheumatism (EULAR) response on their current dose of infliximab. Patients who do not achieve a EULAR response will increase their dose from 3mg/kg to 5 mg/kg at week 14. Patients who do not achieve a EULAR response at week 22 will increase from either 3 mg/kg to 5 mg/kg or from 5mg/kg to 7 mg/kg. The last study infusion will take place at week 22. The last study visit for effectiveness evaluations will take place at week 26. A week 30 follow-up visit will be performed for adverse events and tuberculosis evaluations, health economics assessments, and review of concomitant medications. All patients who end the study early will be required to complete all assessments. All joint assessments will be performed by an independent joint assessor at each study site and will be blinded to study treatments patients are receiving. The independent joint assessor will only perform joint assessments for study patients and will not perform or assist in any other study assessment. Patients will receive 3 mg/kg infliximab infusions at weeks 0, 2, and 6. If patients achieve European League Against Rheumatism (EULAR) response, they will remain on their current dose. Patients who do not demonstrate a EULAR response will increase their infliximab dose from 3 mg/kg to 5 mg/kg at week 14. At week 22, patients will also increase their infliximab dose from 3 mg/kg to 5mg/kg or from 5 mg/kg to 7mg/kg if they do not demonstrate a EULAR response.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Centocor, Inc. ( Sr. Dir., Medical Affairs Strategic Trials Team ) |
| Study ID Numbers: | CR013879, C0168Z05 |
| Study First Received: | July 10, 2008 |
| Last Updated: | November 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00714493 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Rheumatoid arthritis Remicade Infliximab Centocor Etanercept Enbrel |
Adalimumab Humira Restart Swollen joints Tender joints. |
|
Anti-Inflammatory Agents Autoimmune Diseases Immune System Diseases Infliximab Joint Diseases Arthritis, Rheumatoid Gastrointestinal Agents Rheumatic Diseases |
Pharmacologic Actions Musculoskeletal Diseases Arthritis Therapeutic Uses Connective Tissue Diseases Antirheumatic Agents Dermatologic Agents |