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RESTART C0168Z05 Rheumatoid Arthritis Study
This study is ongoing, but not recruiting participants.
First Received: July 10, 2008   Last Updated: November 19, 2009   History of Changes
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�).

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714493

Sponsors and Collaborators
Centocor, Inc.
Schering-Plough
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided

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

Keywords provided by Centocor, Inc.:
Rheumatoid arthritis
Remicade
Infliximab
Centocor
Etanercept
Enbrel
Adalimumab
Humira
Restart
Swollen joints
Tender joints.

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009