Prospective, observational, parallel-group, postmarketing safety surveillance registry in participants treated with Remicade or standard therapy for active or fistulizing Crohn's disease (CD). The follow-up period is up to 5 years. The participants in the standard therapy group may switch over to Remicade any time during the follow-up period
Study Type
OBSERVATIONAL
Enrollment
2,662
The treating physician will determine the treatment regimen and dose of Remicade.
Number of Participants With Serious Infections
The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii \[PCP\] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections.
Time frame: Up to 5 Years
Number of Participants With Infusion-Related Reactions/Hypersensitivity
The number of participants with infusion-related reactions and/or hypersensitivity was evaluated. An infuson-related reaction/hypersensitivity was defined as as an acute reaction, including anaphylactic shock that occurs after the onset of the infusion or within the 1- to 2-hour observation period following the end of the infusion. Delayed hypersensitivity reactions (myalgia and/or arthralgia with fever and rash within 14 days of the infusion) were included.
Time frame: Up to 5 Years
Number of Participant Fatalities
The number of participant fatalities was evaluated throughout the study.
Time frame: Up to 5 Years
Number of Participants With New or Worsening Congestive Heart Failure
The number of participants with new or worsening congestive heart failure was evaluated throughout the study.
Time frame: Up to 5 Years
Number of Participants With Demyelinating Neurological Disorders
The number of participants with demyelinating neurological disorders was evaluated. Demyelinating neurological disorders were defined as multiple sclerosis, optic neuritis, peripheral syndromes such as peripheral neuropathy, mononeuropathy multipex, cranial neuropathies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, and transverse myelitis.
Time frame: Up to 5 Years
Number of Participants With Hematologic Conditions
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The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia.
Time frame: Up to 5 Years
Number of Participants With Lymphoproliferative Disorders/Malignancies
The number of participants wtih lymphoproliferative disorders and/or malignancies was evaluated. A lymphoproliferative disorder and /or malignancy included, but was not limited to, lymphoma, gastrointestinal cancer, skin cancer (including basocellular and squamous carcinoma, melanoma) and in situ cervical carcinoma.
Time frame: Up to 5 Years
Participant Assessment of Overall Health Status By Study Visit
The participant assessment of overall health status was evaluated at baseline and each study visit. The overall health status questionnaire asked participants to rate their current health status over the prior 24 hours as 1=best possible, 2=much better than average, 3=better than average, 4=average, 5=worse than average, 6=much worse than average, or 7=worst possible. Scores ranged from 1 to 7 with lower scores indicating better health status.
Time frame: Up to 5 Years
The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit
The Harvey-Bradshaw Index of Crohn's Disease Acitivity was evaluated at each study visit. The Harvey-Bradshaw Index evaluates participants' general health in the day prior in the domains of well being, abdominal pain, number of liquid stools per day, and abdominal mass and complications and was evaluated on the day of the study visit. The score is derived from a 0-4 score for general well being, 0-3 for abdmonial pain, raw score for number of liquid stools per day, 0-3 for abdominal mass, and raw score for complications. The total score is from 0 to infinity, with lower scores indicating better outcomes.
Time frame: Up to 5 Years
Work/Daily Activity Status Score By Study Visit
The participant work/daily activity status score was evaluated at each study visit. The work/daily activity questionnaire asked participants to rate their level of daily functioning on a scale of 1 to 10 with a lower score indicating less of an impact of Crohn's disease on work or daily life functioning.
Time frame: Up to 5 Years
Number of Participants With a Draining Fistula By Study Visit
The number of participants with a draining fistula was evaluated at each study visit.
Time frame: Up to 5 Years
Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.
Time frame: Up to 5 Years
Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.
Time frame: Up to 5 Years
Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months
The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit.
Time frame: Up to 5 Years