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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:  NCT00650078
Date of registration: 28/03/2008
Prospective Registration: Yes
Primary sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland
Public title: Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis CAPRA-2
Scientific title: A Randomized Multi-Center, Double-Blind, Placebo-Controlled Study of a New Modified-Release Tablet Formulation of Prednisone (Lodotra®) in Patients With Rheumatoid Arthritis
Date of first enrolment: March 2008
Target sample size: 350
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00650078
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Canada Germany Hungary Poland United Kingdom United States
Contacts
Name:     Frank Buttgereit, Prof. Dr.
Address: 
Telephone:
Email:
Affiliation:  Charité Campus Mitte, Germany
Key inclusion & exclusion criteria

Inclusion Criteria:

- Documented history of RA in agreement with ACR criteria

- DMARD treatment for RA greater than or equal to 6 months, with a stable dose greater
than or equal to 6 weeks prior to screening visit

- Duration of morning stiffness greater than or equal to 45 minutes

- greater than or equal to 4 swollen joints (out of 28)

- greater than or equal to 4 tender joints (out of 28)

Exclusion Criteria:

- Suffering from another disease, which requires glucocorticoid treatment during the
study period

- Synovectomy within 4 months prior to study start

- Use of glucocorticoids:

- Continued use of systemic glucocorticoids within 4 weeks prior to screening visit

- Intermittent use of glucocorticoids within 2 weeks prior to screening visit.

- Joint injections within 6 weeks prior to screening visit

- Topical glucocorticoids must be stopped at screening visit

- Use of biologicals such as: tumor necrosis factor a (TNFa) inhibitors and other
compounds within 5 serum half lives prior to screening visit

- Pregnancy or nursing



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: MR prednisone
Drug: Placebo
Primary Outcome(s)
ACR 20 Response Rate at Visit 4 [Time Frame: Week 12]
Secondary Outcome(s)
Relative Reduction of Morning Stiffness [Time Frame: Week 12]
Secondary ID(s)
EudraCT-Number: 2007-003508-36
NP01-007
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 13/12/2012
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00650078
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