Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis (CAPRA-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Horizon Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00650078
First received: March 28, 2008
Last updated: April 23, 2013
Last verified: April 2013
Results First Received: November 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: MR prednisone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Approximately 350 patients were to be enrolled (at screening, Visit 0), with a minimum of 6 and a maximum of 28 patients at each center. It was planned to randomize (at Visit 1) a total of 294 patients in 50-55 centers in North America and Europe (Germany, Hungary, Poland and UK). First patient enrolled March, 2008; last patient contact May, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a 1 week screening phase followed by a 12 week double blind treatment phase. In addition to their standard RA medication, patients received placebo during the 1 week screening phase. The purpose of the screening phase was to establish the patient's compliance with study medication and completion of diary entries.

Reporting Groups
  Description
NP01 Modified Release (MR) prednisone 5 mg
Placebo No text entered.

Participant Flow:   Overall Study
    NP01     Placebo  
STARTED     231     119  
COMPLETED     217     106  
NOT COMPLETED     14     13  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
NP01 Modified Release (MR) prednisone 5 mg
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    NP01     Placebo     Total  
Number of Participants  
[units: participants]
  231     119     350  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     186     95     281  
>=65 years     45     24     69  
Age  
[units: years]
Mean ± Standard Deviation
  57.1  ± 9.89     57.5  ± 9.55     57.2  ± 9.76  
Gender  
[units: participants]
     
Female     192     102     294  
Male     39     17     56  
Region of Enrollment  
[units: participants]
     
United States     48     27     75  
Hungary     67     35     102  
Canada     8     5     13  
Poland     98     47     145  
Germany     1     2     3  
United Kingdom     9     3     12  



  Outcome Measures
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1.  Primary:   ACR 20 Response Rate at Visit 4   [ Time Frame: Week 12 ]

2.  Secondary:   Relative Reduction of Morning Stiffness   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Senior Vice President, Clinical Development & Operations
Organization: Horizon Pharma
phone: 224-383-3012
e-mail: agrahn@horizonpharma.com


No publications provided


Responsible Party: Horizon Pharma, Inc.
ClinicalTrials.gov Identifier: NCT00650078     History of Changes
Other Study ID Numbers: NP01-007, EudraCT-Number: 2007-003508-36
Study First Received: March 28, 2008
Results First Received: November 1, 2012
Last Updated: April 23, 2013
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Canada: Health Canada