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Special Investigation in Patients With Crohn's Disease (All Patients Investigation)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01298648
First received: January 26, 2011
Last updated: March 19, 2014
Last verified: March 2014

January 26, 2011
March 19, 2014
November 2010
February 2013   (final data collection date for primary outcome measure)
  • Number of Participants With Adverse Events (AEs) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Crohn's Disease Activity Index (CDAI) at Baseline and Week 8 [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    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.
  • Crohn's Disease Activity Index (CDAI) at Baseline and Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Crohn's Disease Activity Index [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
  • Crohn's Disease Activity Index [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01298648 on ClinicalTrials.gov Archive Site
  • Improvement Rating by Investigator at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Effectiveness evaluation by the investigator [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
The level of improvement (markedly improved, improved, not improved, or not assessable) will be rated by comparing clinical condition at week 24 of treatment
Not Provided
Not Provided
 
Special Investigation in Patients With Crohn's Disease (All Patients Investigation)
Special Investigation (All Cases Investigation in Patients With Crohn's Disease)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

All patients who receive Humira for the treatment of Crohn's Disease

Crohn's Disease
Not Provided
Humira
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1716
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients with moderate or severe active Crohn's disease who are not responding well to conventional therapy and receive Humira will be enrolled in the survey

Exclusion Criteria:

Contraindications according to the Package Insert

  • Patients who have serious infections
  • Patients who have tuberculosis
  • Patients with a history of hypersensitivity to any ingredient of Humira
  • Patients who have demyelinating disease or with a history of demyelinating disease
  • Patients who have congestive cardiac failure
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01298648
P12-706
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Sadanori Abe AbbVie GK
AbbVie
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP