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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 10, 2008 | ||||
| Last Updated Date | November 19, 2009 | ||||
| Start Date ICMJE | June 2008 | ||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Assess the effectiveness of infliximab in patients with active rheumatoid arthritis who achieve a EULAR response at week 10 [ Time Frame: Week 10 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Assess the effectiveness of infliximab in patients with active rheumatoid arthritis who achieve a EULAR response at week 10 | ||||
| Change History | Complete list of historical versions of study NCT00714493 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Assess clinical response, physical function, and health-related quality of life through week 26 in patients with active rheumatoid arthritis who are having an inadequate response to etanercept or adalimumab. [ Time Frame: Clinical response, physical function, and health-related quality of life through Week 26; health economics through Week 30. ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Assess clinical response, physical function, and health-related quality of life through week 26 in patients with active rheumatoid arthritis who are having an inadequate response to etanercept or adalimumab. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | RESTART C0168Z05 Rheumatoid Arthritis Study | ||||
| Official Title ICMJE | 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�). | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Rheumatoid Arthritis | ||||
| Intervention ICMJE | Biological: Infliximab | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 203 | ||||
| Estimated Completion Date | May 2010 | ||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00714493 | ||||
| Responsible Party | Sr. Dir., Medical Affairs Strategic Trials Team, Centocor, Inc. | ||||
| Study ID Numbers ICMJE | CR013879, C0168Z05 | ||||
| Study Sponsor ICMJE | Centocor, Inc. | ||||
| Collaborators ICMJE | Schering-Plough | ||||
| Investigators ICMJE |
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| Information Provided By | Centocor, Inc. | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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