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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:
ClinicalTrials.gov Identifier:
NCT00650078
First Posted: April 1, 2008
Last Update Posted: April 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Horizon Pharma Ireland, Ltd., Dublin Ireland
Results First Submitted: November 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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
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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 
Overall Participants Analyzed 
[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


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Senior Vice President, Clinical Development & Operations
Organization: Horizon Pharma
phone: 224-383-3012
e-mail: agrahn@horizonpharma.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Horizon Pharma Ireland, Ltd., Dublin Ireland
ClinicalTrials.gov Identifier: NCT00650078     History of Changes
Other Study ID Numbers: NP01-007
EudraCT-Number: 2007-003508-36
First Submitted: March 28, 2008
First Posted: April 1, 2008
Results First Submitted: November 1, 2012
Results First Posted: December 13, 2012
Last Update Posted: April 30, 2013