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

• Number of Participants Experiencing at Least One Adverse Event [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: Yes ]
  An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the treatment, was also an adverse event.
  
  

• Clinicians' Impression of Disease Severity From Baseline to Week 102 [ Time Frame: Baseline, Week 6, Week 14, Week 22, Week 54, Week 102 ] [ Designated as safety issue: No ]
  Participant severity of disease was assessed at baseline, Week 6, Week 14, Week 22, Week 54, and Week 102 on the basis of the treating clinician's opinion of the participant being normal, not at all ill, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, or extreme severe illness. Each time point was compared to the previous visit.
  
  
• Clinicians' Impression of Therapeutic Efficacy [ Time Frame: Week 6, Week 14, Week 22, Week 54, Week 102 ] [ Designated as safety issue: No ]
  Therapeutic efficacy was rated by the treating physician at each time point as moderate-to-clear improvement, no change, not assessable, mild-to-slight improvement, very good-to-full improvement, or worsened. Each time point was compared to the previous visit.
  
  

The study population was chosen from a non-probability sample.

The safety population consisted of all participants with at least one documented infusion of infliximab.

The evaluable population consisted of all participants that were >=18 years of age with a recorded indication for infliximab use, that had available baseline data, and with at least 3 infusions of infliximab within the first 16 weeks of the study. Baseline characteristics are provided for this population.