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A Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting (InspirAda)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01550965
First Posted: March 12, 2012
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
Results First Submitted: April 1, 2016  
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
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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
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 463 participants were enrolled: 461 in the intent to treat (ITT) population were analyzed for efficacy (excluding 2 due to lack of post-baseline measurement data); 463 were analyzed for safety (participants who had received at least one dose of study drug).

Reporting Groups
  Description
Participants Receiving Adalimumab Adults with active ulcerative colitis (UC) who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.

Participant Flow:   Overall Study
    Participants Receiving Adalimumab
STARTED   463 
COMPLETED   353 
NOT COMPLETED   110 
Adverse Event                26 
Withdrawal by Subject                10 
Lost to Follow-up                2 
Lack of Efficacy                59 
Not Specified                13 



  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.
Intention to Treat (ITT) population: all participants who had received at least one dose of study drug and had data for at least one post-baseline assessment of any effectiveness measurement [up to and including Week 26] while receiving treatment with adalimumab.

Reporting Groups
  Description
Participants Receiving Adalimumab Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.

Baseline Measures
   Participants Receiving Adalimumab 
Overall Participants Analyzed 
[Units: Participants]
 461 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.8  (13.75) 
Gender 
[Units: Participants]
 
Female   206 
Male   255 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score   [ Time Frame: Week 0 (baseline) and Week 26 ]

2.  Primary:   Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Costs of UC-related Medical Care Excluding Adalimumab Costs   [ Time Frame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months) ]

3.  Secondary:   Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Total All-cause Direct Health Care Costs (Excluding Adalimumab Costs)   [ Time Frame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months) ]

4.  Secondary:   Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Direct and Indirect Health Care Costs   [ Time Frame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months) ]

5.  Secondary:   Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related and All-cause Hospitalization   [ Time Frame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months) ]

6.  Secondary:   Mean Change From Baseline in Participant's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM)   [ Time Frame: Week 0 (baseline) and Week 26 ]

7.  Secondary:   Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Outpatient Utilization, Including Emergency Department Visits, Unscheduled Consultation, Exam Procedures   [ Time Frame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months) ]

8.  Secondary:   Percentage of Participants With Absence of Blood in Stool   [ Time Frame: Week 26 ]

9.  Secondary:   Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time   [ Time Frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26 ]

10.  Secondary:   Mean Change From Baseline in Physician's Global Assessment (PGA)   [ Time Frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26 ]

11.  Secondary:   Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI)   [ Time Frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26 ]

12.  Secondary:   Mean Change From Baseline in European Quality of Life – 5 Dimensions – 5 Level (EQ-5D-5L) Total Score   [ Time Frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26 ]

13.  Secondary:   Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed   [ Time Frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26 ]

14.  Secondary:   Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working   [ Time Frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26 ]

15.  Secondary:   Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage   [ Time Frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26 ]

16.  Secondary:   Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment   [ Time Frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


Results Point of Contact:  
Name/Title: Global Medical Information
Organization: AbbVie
phone: 800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01550965     History of Changes
Other Study ID Numbers: M13-045
2011-002411-29 ( EudraCT Number )
First Submitted: March 8, 2012
First Posted: March 12, 2012
Results First Submitted: April 1, 2016
Results First Posted: November 1, 2016
Last Update Posted: November 1, 2016