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: October 5, 2012
Last verified: September 2012
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Show All Outcome Measures

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


  More Information
  Hide More Information

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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@Merck.com


No publications provided


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: October 5, 2012
Health Authority: Germany: Paul-Ehrlich-Institut