World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00714493
Date of registration: 10/07/2008
Prospective Registration: Yes
Primary sponsor: Centocor Ortho Biotech Services, L.L.C.
Public title: RESTART C0168Z05 Rheumatoid Arthritis Study
Scientific 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).
Date of first enrolment: July 2008
Target sample size: 203
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00714493
Study type:  Interventional
Study design:   
Phase:  Phase 4
Countries of recruitment
Austria Belgium Canada Finland France Germany Israel Netherlands
Spain United Kingdom United States
Contacts
Name:     Centocor Ortho Biotech Services, L.L.C. Clinical Trial
Address: 
Telephone:
Email:
Affiliation:  Centocor Ortho Biotech Services, L.L.C.
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Biological: Infliximab
Primary Outcome(s)
Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10 [Time Frame: Week 10]
Secondary Outcome(s)
Change From Baseline in Physical Function (HAQ) [Time Frame: Week 10]
Change From Baseline in Physical Function (HAQ) [Time Frame: Week 26]
Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase [Time Frame: Week 26]
Percent of Patients Who Achieved ACR20 at Week 10 [Time Frame: Week 10]
Percent of Patients Who Achieved ACR20 at Weeks 26. [Time Frame: 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 [Time Frame: Week 26]
Secondary ID(s)
C0168Z05
CR013879
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Schering-Plough
Ethics review
Results
Results available: Yes
Date Posted: 09/02/2011
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00714493
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history