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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00746512
First received: September 3, 2008
Last updated: May 14, 2014
Last verified: May 2014
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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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.
No text entered.

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 ]

2.  Secondary:   Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])   [ Time Frame: Baseline and Day 14 ]


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


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00746512     History of Changes
Other Study ID Numbers: 0000-088, 2008_531
Study First Received: September 3, 2008
Results First Received: December 17, 2010
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board