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A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00746512
First received: September 3, 2008
Last updated: March 10, 2011
Last verified: March 2011
History of Changes
Results First Received: December 17, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Prednisone 15 mg
Drug: Placebo Tablets
Drug: Prednisone 7.5 mg
Drug: Placebo Over-Encapsulated Tablets

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Prednisone 15 mg Prednisone 15 mg tablets once daily for 15 days
Placebo 15 mg Prednisone 15 mg placebo tablets once daily for 15 days
Prednisone 7.5 mg

Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days

As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
Placebo 7.5 mg

Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days

As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.

Participant Flow:   Overall Study
    Prednisone 15 mg     Placebo 15 mg     Prednisone 7.5 mg     Placebo 7.5 mg  
STARTED     8     10     18     9  
COMPLETED     8     10     18     9  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Prednisone 15 mg Prednisone 15 mg tablets once daily for 15 days
Placebo 15 mg Prednisone 15 mg placebo tablets once daily for 15 days
Prednisone 7.5 mg

Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days

As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
Placebo 7.5 mg

Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days

As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
Total Total of all reporting groups

Baseline Measures
    Prednisone 15 mg     Placebo 15 mg     Prednisone 7.5 mg     Placebo 7.5 mg     Total  
Number of Participants  
[units: participants]
 		  8     10     18     9     45  
Age  
[units: years]
Mean ( Full Range ) 		  61.6  
  ( 48 to 69 )   		  58.4  
  ( 45 to 86 )   		  57.9  
  ( 37 to 81 )   		  55.1  
  ( 32 to 71 )   		  58.1  
  ( 32 to 86 )  
Gender  
[units: participants]
 		         
Female     6     5     12     6     29  
Male     2     5     6     3     16  



  Outcome Measures
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1.  Primary:   Synovial Blood Flow   [ Time Frame: Baseline and Day 14 ]
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2.  Secondary:   Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])   [ Time Frame: Baseline and Day 14 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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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.


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: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00746512     History of Changes
Other Study ID Numbers: MK-0000-088, 2008_531
Study First Received: September 3, 2008
Results First Received: December 17, 2010
Last Updated: March 10, 2011
Health Authority: United States: Institutional Review Board