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).
2 other identifiers
interventional
203
10 countries
76
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 rheumatoid-arthritis
Started Jul 2008
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 10, 2008
CompletedFirst Posted
Study publicly available on registry
July 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
February 9, 2011
CompletedSeptember 12, 2013
August 1, 2013
1.5 years
July 10, 2008
January 14, 2011
August 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10
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.
Week 10
Secondary Outcomes (6)
Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase
Week 26
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
Week 26
Change From Baseline in Physical Function (HAQ)
Week 10
Change From Baseline in Physical Function (HAQ)
Week 26
Percent of Patients Who Achieved ACR20 at Week 10
Week 10
- +1 more secondary outcomes
Study Arms (1)
001
OTHERInfliximab3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor Ortho Biotech Services, L.L.C.lead
- Schering-Ploughcollaborator
Study Sites (76)
Unknown Facility
Huntsville, Alabama, United States
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Paradise Valley, Arizona, United States
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Tucson, Arizona, United States
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Santa Monica, California, United States
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Bridgeport, Connecticut, United States
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Lewes, Delaware, United States
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Boca Raton, Florida, United States
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Palm Harbor, Florida, United States
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Tamarac, Florida, United States
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Vero Beach, Florida, United States
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Atlanta, Georgia, United States
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Moline, Illinois, United States
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Springfield, Illinois, United States
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Lexington, Kentucky, United States
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Wheaton, Maryland, United States
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Saint Clair Shores, Michigan, United States
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Eagan, Minnesota, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Berkeley Heights, New Jersey, United States
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Freehold, New Jersey, United States
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Albany, New York, United States
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Syracuse, New York, United States
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Chapel Hill, North Carolina, United States
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Columbus, Ohio, United States
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Mayfield, Ohio, United States
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Middleburg Heights, Ohio, United States
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Tulsa, Oklahoma, United States
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Allentown, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Wexford, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Jackson, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Mesquite, Texas, United States
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Temple, Texas, United States
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Tyler, Texas, United States
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Burke, Virginia, United States
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Reston, Virginia, United States
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Seattle, Washington, United States
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Graz-Eggenberg, Austria
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Vienna, Austria
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Toronto, Ontario, Canada
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Hamilton Ontario, Canada
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Helsinki, Finland
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Bordeaux, France
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Limoges, France
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Montivilliers, France
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Orléans, France
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Frankfurt, Germany
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Holdenfelde, Germany
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Leipzig, Germany
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München, Germany
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Ratingen, Germany
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Ashkelon, Israel
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Beer Yaakov, Israel
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Haifa, Israel
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Kfar Saba, Israel
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Ramat Gan, Israel
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Rehovot, Israel
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Tel Aviv, Israel
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Alkmaar, Netherlands
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Madrid, Spain
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Oviedo, Spain
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Santiago de Compostela, Spain
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Leeds, United Kingdom
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London, United Kingdom
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Wigan, United Kingdom
Related Publications (1)
Fleischmann R, Goldman JA, Leirisalo-Repo M, Zanetakis E, El-Kadi H, Kellner H, Bolce R, DeHoratius R, Wang J, Decktor D. Infliximab efficacy in rheumatoid arthritis after an inadequate response to etanercept or adalimumab: results of a target-driven active switch study. Curr Med Res Opin. 2014 Nov;30(11):2139-49. doi: 10.1185/03007995.2014.942416. Epub 2014 Jul 30.
PMID: 25050591DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Director, Clinical Research - Medical Affairs
- Organization
- Centocor Ortho Biotech, Inc.
Study Officials
- STUDY DIRECTOR
Centocor Ortho Biotech Services, L.L.C. Clinical Trial
Centocor Ortho Biotech Services, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2008
First Posted
July 14, 2008
Study Start
July 1, 2008
Primary Completion
January 1, 2010
Study Completion
June 1, 2010
Last Updated
September 12, 2013
Results First Posted
February 9, 2011
Record last verified: 2013-08