RESTART C0168Z05 Rheumatoid Arthritis Study

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier:
NCT00714493
First received: July 10, 2008
Last updated: August 29, 2013
Last verified: August 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Ortho Biotech Services, L.L.C.:

Primary Outcome Measures:
  • Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10 [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    Percent of patients who achieved EULAR response at Week 10. EULAR response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). At a given visit, patients with a DAS28 score of ≤ 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is greater than 0.6; Or patients with a DAS28 score > 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is > 1.2.


Secondary Outcome Measures:
  • Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Percent of patients who achieved EULAR response at Week 10 and maintained through Week 26 without infliximab dose increase

  • Percent of Patients Who Achieved EULAR Response at Week 26, Regardless of EULAR Response Status at Weeks 10, 14, and 22, With or Without Dose Increase Prior to Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Percent of patients who achieved EULAR response at Week 26, regardless of EULAR response status at Weeks 10, 14, and 22, with or without dose increase prior to Week 26

  • Change From Baseline in Physical Function (HAQ) [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    Change from baseline in physical function (HAQ) at Week 10. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 10 value minus baseline value. A negative value in change from baseline indicates an improvement.

  • Change From Baseline in Physical Function (HAQ) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Change from baseline in physical function (HAQ) at Week 26. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 26 value minus baseline value. A negative value in change from baseline indicates an improvement.

  • Percent of Patients Who Achieved ACR20 at Week 10 [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    Percent of patients who achieved ACR20 at Week 10. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient's assessment of pain visual analog scale (VAS), Patient's global assessment of disease activity (VAS), Evaluator's global assessment of disease activity (VAS), Patient's assessment of physical function as measured by the HAQ disability index, and CRP.

  • Percent of Patients Who Achieved ACR20 at Weeks 26. [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Percent of patients who achieved ACR20 at Weeks 26. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient's assessment of pain visual analog scale (VAS), Patient's global assessment of disease activity (VAS), Evaluator's global assessment of disease activity (VAS), Patient's assessment of physical function as measured by the HAQ disability index, and CRP.


Enrollment: 203
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
001
Infliximab3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
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. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 77 Study Locations
Sponsors and Collaborators
Centocor Ortho Biotech Services, L.L.C.
Schering-Plough
Investigators
Study Director: Centocor Ortho Biotech Services, L.L.C. Clinical Trial Centocor Ortho Biotech Services, L.L.C.
  More Information

No publications provided

Responsible Party: Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier: NCT00714493     History of Changes
Obsolete Identifiers: NCT01281449
Other Study ID Numbers: CR013879, C0168Z05
Study First Received: July 10, 2008
Results First Received: January 14, 2011
Last Updated: August 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor Ortho Biotech Services, L.L.C.:
rheumatoid arthritis
remicade
infliximab
Centocor
etanercept
enbrel
adalimumab
humira
restart
swollen joints
tender joints.

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014