Remission in Subjects With Crohn's Disease, 1 Year Phase (CLASSICII)

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00055497
First received: March 3, 2003
Last updated: April 7, 2011
Last verified: April 2011
Results First Received: December 15, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Crohn's Disease
Interventions: Biological: Double-blind (DB) adalimumab placebo
Biological: DB adalimumab 40 mg eow
Biological: DB adalimumab 40 mg ew
Biological: OL adalimumab 40 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
276 participants were enrolled in the present study from 53 sites in the United States (US), Canada, Poland, Belgium, the Netherlands, and Czech Republic. The first visit in the present study for the first participant was 28 August 2002 and the final visit for the last participant occurred on 12 January 2005.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study was rollover of NCT00055523; screening done in NCT00055523. At Week 4 of NCT00055497, 55 remitters at Week 0 and Week 4 of Study NCT00055497 were randomized to DB therapy; 204 non-remitters were assigned to OL adalimumab. 17 discontinued before/at Week 4, included in OL group for Participant Flow and AEs because they were not randomized.

Reporting Groups
  Description
DB Placebo Double-blind adalimumab placebo every week.
DB Adalimumab 40 mg Every Other Week (Eow) Double-blind adalimumab 40 mg every other week (injection received every week; placebo received when active drug not received)
DB Adalimumab 40 mg Every Week (ew) Double-blind adalimumab 40 mg every week.
OL Adalimumab 40 mg Open-label adalimumab 40 mg every other week or every week.

Participant Flow:   Overall Study
    DB Placebo     DB Adalimumab 40 mg Every Other Week (Eow)     DB Adalimumab 40 mg Every Week (ew)     OL Adalimumab 40 mg  
STARTED     18     19     18     221 [1]
COMPLETED     13 [2]   16 [2]   16 [2]   131 [2]
NOT COMPLETED     5     3     2     90  
Adverse Event                 1                 1                 1                 28  
Withdrawal by Subject                 3                 1                 1                 15  
Lost to Follow-up                 0                 1                 0                 5  
Protocol Violation                 0                 0                 0                 3  
Lack of Efficacy                 1                 0                 0                 27  
Administrative Reasons                 0                 0                 0                 1  
Unknown                 0                 0                 0                 11  
[1] 17 participants who discontinued at/before Week 4 are counted here because they were not randomized.
[2] Participants may have continued to the open-label extension study. See NCT01070303.



  Baseline Characteristics
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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
DB Placebo No text entered.
DB Adalimumab 40 mg Every Other Week (Eow) No text entered.
DB Adalimumab 40 mg Every Week No text entered.
OL Adalimumab 40 mg Eow Participants who did not continue at Week 4 are not included in Baseline summary.
Total Total of all reporting groups

Baseline Measures
    DB Placebo     DB Adalimumab 40 mg Every Other Week (Eow)     DB Adalimumab 40 mg Every Week     OL Adalimumab 40 mg Eow     Total  
Number of Participants  
[units: participants]
  18     19     18     204     259  
Age  
[units: Participants]
         
<=18 years     0     0     0     1     1  
Between 18 and 65 years     17     19     18     195     249  
>=65 years     1     0     0     8     9  
Gender [1]
[units: participants]
         
Female     12     12     9     104     137  
Male     6     7     9     100     122  
[1] Baseline data were collected in the lead-in study (NCT00055523) and are reported by treatment group determined at Week 4 of NCT00055497.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI)   [ Time Frame: Week 56 ]

2.  Primary:   Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF)   [ Time Frame: Week 56 ]

3.  Secondary:   Number of Participants Achieving Clinical Remission at Week 24 - NRI   [ Time Frame: Week 24 ]

4.  Secondary:   Number of OL Participants Achieving Clinical Remission at Week 56 - NRI   [ Time Frame: Week 56 ]

5.  Secondary:   Number of Participants Achieving Clinical Response 100 (CR-100) - NRI   [ Time Frame: From Baseline of lead-in study to Week 24 and Week 56 ]

6.  Secondary:   Number of Participants Achieving Clinical Response 70 (CR-70)- NRI   [ Time Frame: From Baseline of lead-in study to Week 24 and to Week 56 ]

7.  Secondary:   Number of Participants Achieving Clinical Remission at Week 24 - LOCF   [ Time Frame: Week 24 ]

8.  Secondary:   Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF   [ Time Frame: Week 56 ]

9.  Secondary:   Number of Participants Achieving CR-100 - LOCF   [ Time Frame: From Baseline of lead-in study to Week 24 and Week 56 ]

10.  Secondary:   Number of Participants Achieving CR-70 - LOCF   [ Time Frame: From Baseline of lead-in study to Week 24 and Week 56 ]

11.  Secondary:   Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF   [ Time Frame: Change from Baseline of lead-in study to Week 24 and Week 56 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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: Global Medical Services
Organization: Abbott
phone: 800-633-9110


No publications provided by Abbott

Publications automatically indexed to this study:

Responsible Party: Anne Camez, Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00055497     History of Changes
Other Study ID Numbers: M02-433
Study First Received: March 3, 2003
Results First Received: December 15, 2009
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration