Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00408629
First received: December 5, 2006
Last updated: April 28, 2011
Last verified: April 2011
Results First Received: March 3, 2011  
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: Ulcerative Colitis
Interventions: Biological: adalimumab
Biological: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Adalimumab 160/80/40 During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
Placebo The placebo treatment group received placebo throughout the Double-Blind (DB) period.

Participant Flow:   Overall Study
    Adalimumab 160/80/40     Placebo  
STARTED     258 [1]   260 [2]
COMPLETED     161 [3]   135  
NOT COMPLETED     97     125  
Adverse Event                 13                 27  
Withdrawal by Subject                 8                 4  
Lost to Follow-up                 1                 1  
Lack of Efficacy                 63                 73  
Protocol Violation                 1                 5  
Miscellaneous                 11                 15  
[1] 10 ADA recipients from 3 noncompliant clinical sites in Safety, but not in Efficacy analyses (248).
[2] 14 PLB recipients from 3 noncompliant clinical sites in Safety, but not in Efficacy analyses (246).
[3] 1 ADA recipient did not receive study drug and discontinued due to other reasons.



  Baseline Characteristics
  Hide Baseline Characteristics

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
Adalimumab 160/80/40 During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
Placebo The placebo treatment group received placebo throughout the Double-Blind (DB) period.
Total Total of all reporting groups

Baseline Measures
    Adalimumab 160/80/40     Placebo     Total  
Number of Participants  
[units: participants]
  248     246     494  
Age [1]
[units: Years]
Mean ± Standard Deviation
  39.6  ± 12.47     41.3  ± 13.22     40.4  ± 12.86  
Age, Customized  
[units: Participants]
     
< 40 years     136     118     254  
40 to 64 years     105     116     221  
>=65 years     7     12     19  
Gender  
[units: Participants]
     
Female     106     94     200  
Male     142     152     294  
Region of Enrollment  
[units: Participants]
     
Portugal     2     1     3  
United States     78     82     160  
Spain     4     7     11  
Austria     0     4     4  
Israel     5     0     5  
France     18     14     32  
Czech Republic     18     25     43  
Hungary     13     13     26  
Canada     18     19     37  
Poland     14     15     29  
Belgium     26     18     44  
Australia     11     9     20  
Denmark     2     3     5  
Norway     5     1     6  
Germany     19     22     41  
New Zealand     4     4     8  
Switzerland     11     9     20  
[1] The ITT analysis set, defined as all participants who were randomized in the study excluding participants from 3 non-compliant sites, was used to determine all Baseline measures (continuous age, customized age, gender, and region of enrollment).



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 8   [ Time Frame: Week 8 ]

2.  Primary:   Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 52   [ Time Frame: Week 52 ]

3.  Secondary:   Proportion of Participants Who Achieved Sustained Clinical Remission Per Mayo Score at Both Week 8 and Week 52   [ Time Frame: Week 8, Week 52 ]

4.  Secondary:   Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 8   [ Time Frame: Week 8 ]

5.  Secondary:   Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 52   [ Time Frame: Week 52 ]

6.  Secondary:   Proportion of Participants Who Achieved Sustained Clinical Response Per Mayo Score at Both Week 8 and Week 52   [ Time Frame: Week 8, Week 52 ]

7.  Secondary:   Proportion of Participants Who Achieved Mucosal Healing at Week 8   [ Time Frame: Week 8 ]

8.  Secondary:   Proportion of Participants Who Achieved Mucosal Healing at Week 52   [ Time Frame: Week 52 ]

9.  Secondary:   Proportion of Participants Who Achieved Sustained Mucosal Healing at Both Week 8 and Week 52   [ Time Frame: Week 8, Week 52 ]

10.  Secondary:   Proportion of Participants Who Discontinued Corticosteroid Use Before Week 52 and Achieved Clinical Remission Per Mayo Score at Week 52   [ Time Frame: Baseline to Week 52 ]

11.  Secondary:   Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8   [ Time Frame: Week 8 ]

12.  Secondary:   Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8   [ Time Frame: Week 8 ]

13.  Secondary:   Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8   [ Time Frame: Week 8 ]

14.  Secondary:   Proportion of Participants Who Discontinued Corticosteroid Use for At Least 90 Days and Achieved Clinical Remission Per Mayo Score at Week 52   [ Time Frame: Baseline to Week 52 ]

15.  Secondary:   Proportion of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission Per Mayo Score (Sustained) at Both Weeks 32 and 52   [ Time Frame: Week 32, Week 52 ]

16.  Secondary:   Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 52   [ Time Frame: Week 52 ]

17.  Secondary:   Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 8   [ Time Frame: Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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.


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: Roopal B Thakker, M.D./Project Director, Abbott
ClinicalTrials.gov Identifier: NCT00408629     History of Changes
Other Study ID Numbers: M06-827, 2006-002782-40
Study First Received: December 5, 2006
Results First Received: March 3, 2011
Last Updated: April 28, 2011
Health Authority: Canada: Health Canada
United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria : Federal Ministry for Labour, Health, and Social Affairs
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
New Zealand: Medsafe
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
Portugal: National Pharmacy and Medicines Institute
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Switzerland: Swissmedic