Clinical Trial: Special Investigation in Patients With Crohn's Disease (All Patients Investigation)
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Special Investigation (All Cases Investigation in Patients With Crohn's Disease)
Brief Summary: This study will be conducted to assess adverse drug reactions, incidence of adverse events, and factors that may affect the safety and effectiveness of Humira for the treatment of Crohn's disease.
Detailed Summary:
Sponsor: AbbVie (prior sponsor, Abbott)
Current Primary Outcome:
- Number of Participants With Adverse Events (AEs) [ Time Frame: 24 weeks ]An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.
- Crohn's Disease Activity Index (CDAI) at Baseline and Week 4 [ Time Frame: Baseline, Week 4 ]The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.
- Number of patients with adverse events [ Time Frame: at week 24 ]Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
- Crohn's Disease Activity Index [ Time Frame: at week 4 ]
- Crohn's Disease Activity Index [ Time Frame: at week 8 ]
- Crohn's Disease Activity Index [ Time Frame: at week 24 ]
- Improvement Rating by Investigator at Week 24 [ Time Frame: Week 24 ]Overall response rating, according to investigator's subjective clinical opinion. The level of improvement (markedly improved, improved, not improved, or not assessable) was categorized by comparing clinical condition at week 24 or at discontinuation with baseline condition.
- Remission Rate at Week 4, Week 8, and Week 24 [ Time Frame: Baseline, Week 4, Week 8, and Week 24 ]The remission rate for each evaluation timepoint (Weeks 4, 8, and 24) was calculated as the number of participants that had CDAI < 150 divided by the number of participants at Baseline that had CDAI scores ≥ 150.
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome: Effectiveness evaluation by the investigator [ Time Frame: at week 24 ]
Information By: AbbVie
Dates:
Date Received: January 26, 2011
Date Started: November 2010
Date Completion:
Last Updated: March 19, 2014
Last Verified: March 2014
