Phase 3
N=945
Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00409617 ↗Enrolled (actual)
945
Serious AEs
—
Results posted
Sep 2009
Primary outcome: Primary: Number of Participants in Clinical Remission at Treatment Week 20. Clinical Remission Defined as Harvey Bradshaw Index (HBI) Score Less Than 5. — 492 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- adalimumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in Clinical Remission at Treatment Week 20. Clinical Remission Defined as Harvey Bradshaw Index (HBI) Score Less Than 5. |
492 | — |
| SECONDARY Number of Participants Who Were Responders at Week 20 of Treatment. A Responder Was Defined as a Participant Who Had a Decrease of 3 or More on the HBI. |
658 | — |
| SECONDARY Number of Participants Who Had a Reduction in Number of Draining Fistulas of at Least 50% From Baseline to Week 20 |
53 | — |
| SECONDARY Number of Participants Who Had Extra-intestinal Manifestations (EIM) at Baseline and Resolution by Week 20. |
346 | — |
| SECONDARY Mean Change in Total Score of Short Inflammatory Bowel Disease Questionnaire (SIBDQ) From Baseline to Week 20 |
13.2 | — |
| SECONDARY Mean Change in Percent Work Time Missed Due to Crohn's Disease From Baseline to Week 20 of Treatment |
-10.8 | — |
| SECONDARY Mean Change in Percent Impairment While Working From Baseline to Week 20 of Treatment |
-20.0 | — |
| SECONDARY Mean Change in Overall Work Productivity and Activity Impairment Score From Baseline to Week 20 |
-21.8 | — |
| SECONDARY Mean Change in Activity Impairment Score From Baseline to Week 20 |
-23.6 | — |
Summary
The purpose of this study is to evaluate the safety of adalimumab for treatment of patients with moderate to severe Crohn's Disease (CD) and to measure the effects of treatment on patient general well-being, health-related quality of life (QoL), fistula healing, CD-related extra-intestinal manifestations, work performance, and overall activity.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of moderate to severe Crohn's Disease confirmed by endoscopy or radiologic evaluation for greater than 4 months (16 weeks)
- Inadequate response to conventional therapy for Crohn's Disease
- Subjects >=18 and 40 mg/day (or equivalent), subjects on budesonide >9 mg/day, or subjects who are taking prednisone and budesonide concurrently at Baseline
Data sourced from ClinicalTrials.gov (NCT00409617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.