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RESTART C0168Z05 Rheumatoid Arthritis Study
This study is currently recruiting participants.
Study NCT00714493   Information provided by Centocor, Inc.
First Received: July 10, 2008   Last Updated: October 29, 2009   History of Changes

July 10, 2008
October 29, 2009
June 2008
October 2009   (final data collection date for primary outcome measure)
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 ]
Assess the effectiveness of infliximab in patients with active rheumatoid arthritis who achieve a EULAR response at week 10
Complete list of historical versions of study NCT00714493 on ClinicalTrials.gov Archive Site
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 ]
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.
 
RESTART C0168Z05 Rheumatoid Arthritis Study
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�).

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.

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.

Phase IV
Interventional
Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Rheumatoid Arthritis
Biological: Infliximab
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
200
May 2010
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have rheumatoid arthritis
  • Patients must have greater than or equal to 6 tender joints and greater than or equal to 6 swollen joints
  • Patients must have inadequate disease response to etanercept or adalimumab
  • Patients must have received etanercept or adalimumab in combination with methotrexate for a minimum of at least 3 months prior to the screening visit. The last dose of etanercept must have been given at least 1 week but not more than 2 weeks prior to first infliximab infusion. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to first infliximab infusion.

Exclusion Criteria:

  • Patients who have a history of latent or active TB
  • Have inflammatory disease other than rheumatoid arthritis
  • Have had a chronic or recurrent infectious disease.
Both
18 Years and older
No
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: info1@veritasmedicine.com
United States,   Austria,   Canada,   Finland,   France,   Germany,   Israel,   Netherlands,   Spain,   United Kingdom
 
NCT00714493
Sr. Dir., Medical Affairs Strategic Trials Team, Centocor, Inc.
CR013879, C0168Z05
Centocor, Inc.
Schering-Plough
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP