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Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840) (REMission)

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00727298
First received: July 30, 2008
Last updated: November 30, 2015
Last verified: November 2015
Results First Received: August 10, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Arthritis, Rheumatoid
Spondylitis, Ankylosing
Arthritis, Psoriatic
Psoriasis
Crohn's Disease
Intervention: Biological: Infliximab

  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
Of 4485 total enrolled participants, 4465 received at least one infusion of infliximab and are included in the safety evaluation. 3228 of these participants were evaluable for all other study analyses.

Reporting Groups
  Description
Infliximab Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.

Participant Flow:   Overall Study
    Infliximab
STARTED   4485 
COMPLETED   3228 
NOT COMPLETED   1257 



  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
Infliximab Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.

Baseline Measures
   Infliximab 
Overall Participants Analyzed 
[Units: Participants]
 3228 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.3  (13.9) 
Gender, Customized 
[Units: Participants]
 
Female   1591 
Male   1554 
Not Specified   83 


  Outcome Measures
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1.  Primary:   Number of Participants Experiencing at Least One Adverse Event   [ Time Frame: Baseline to Month 24 ]

2.  Secondary:   Clinicians' Impression of Disease Severity From Baseline to Week 102   [ Time Frame: Baseline, Week 6, Week 14, Week 22, Week 54, Week 102 ]

3.  Secondary:   Clinicians' Impression of Therapeutic Efficacy   [ Time Frame: Week 6, Week 14, Week 22, Week 54, Week 102 ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@Merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00727298     History of Changes
Other Study ID Numbers: P04840
Study First Received: July 30, 2008
Results First Received: August 10, 2012
Last Updated: November 30, 2015