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Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT00573794
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : December 19, 2017
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Ulcerative Colitis
Intervention: Biological: adalimumab

  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
A total of 592 subjects were randomized and received at least 1 dose of study drug (safety population); 7 subjects enrolled at 3 noncompliant sites were excluded from the analyses (Intent-to-treat 1 [ITT-1] population; N=585).

Reporting Groups
  Description
Adalimumab 40 mg EOW/EW Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.

Participant Flow:   Overall Study
    Adalimumab 40 mg EOW/EW
STARTED [1]   585 
COMPLETED   255 
NOT COMPLETED   330 
Adverse Event                81 
Withdrew Consent                90 
Lost to Follow-up                13 
Protocol Violation                6 
Lack of Efficacy                94 
Not Specified                46 
[1] ITT-1: All subjects who received ≥1 dose of study drug excluding 7 subjects at noncompliant sites.



  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.
ITT-1: All subjects who received ≥1 dose of study drug excluding 7 subjects at noncompliant sites.

Reporting Groups
  Description
Adalimumab 40 mg EOW/EW Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.

Baseline Measures
   Adalimumab 40 mg EOW/EW 
Overall Participants Analyzed 
[Units: Participants]
 585 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.6  (12.85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      214  36.6% 
Male      371  63.4% 


  Outcome Measures

1.  Primary:   Partial Mayo Score: Change From Baseline Over Time   [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]

2.  Primary:   Mayo Score: Change From Baseline Over Time   [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]

3.  Secondary:   Percentage of Participants With Remission Per Partial Mayo Score Over Time   [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]

4.  Secondary:   Mayo Endoscopy Subscore: Change From Baseline Over Time   [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]

5.  Secondary:   Mayo Rectal Bleeding Subscore: Change From Baseline Over Time   [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]

6.  Secondary:   Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time   [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]

7.  Secondary:   Mayo Stool Frequency Subscore: Change From Baseline Over Time   [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]

8.  Secondary:   Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time   [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]

9.  Secondary:   36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time   [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]

10.  Secondary:   36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time   [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]

11.  Secondary:   Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time   [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]

12.  Secondary:   WPAI:GH Impairment While Working: Change From Baseline Over Time   [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]

13.  Secondary:   WPAI:GH Overall Work Impairment: Change From Baseline Over Time   [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]

14.  Secondary:   WPAI:GH Activity Impairment: Change From Baseline Over Time   [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]

15.  Secondary:   Colectomy Rate   [ Time Frame: 5 years ]

16.  Secondary:   Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations   [ Time Frame: 5 years ]

17.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: From first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks) ]

18.  Secondary:   Hematology: Mean Change From Baseline to Final Values in Hemoglobin   [ Time Frame: Baseline (Week 0), final value (up to 5 years) ]

19.  Secondary:   Hematology: Mean Change From Baseline to Final Values in Hematocrit   [ Time Frame: Baseline (Week 0), final value (up to 5 years) ]

20.  Secondary:   Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils   [ Time Frame: Baseline (Week 0), final value (up to 5 years) ]

21.  Secondary:   Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase   [ Time Frame: Baseline (Week 0), final value (up to 5 years) ]

22.  Secondary:   Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid   [ Time Frame: Baseline (Week 0), final value (up to 5 years) ]

23.  Secondary:   Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides   [ Time Frame: Baseline (Week 0), final value (up to 5 years) ]

24.  Secondary:   Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein   [ Time Frame: Baseline (Week 0), final value (up to 5 years) ]

25.  Secondary:   Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein   [ Time Frame: Baseline (Week 0), final value (up to 5 years) ]


  Serious Adverse Events


  Other Adverse Events


  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
Efficacy data after Week 292 should be interpreted with caution because less than 10% of subjects were under observation beyond Week 292.


  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: AbbVie
phone: 800-633-9110


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00573794     History of Changes
Other Study ID Numbers: M10-223
2007-004157-28 ( EudraCT Number )
First Submitted: December 12, 2007
First Posted: December 14, 2007
Results First Submitted: November 21, 2017
Results First Posted: December 19, 2017
Last Update Posted: February 20, 2018