Phase 3
N=304
Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00427921 ↗Enrolled (actual)
304
Serious AEs
—
Results posted
Oct 2009
Primary outcome: Primary: Mean Extent of Exposure - Duration in Days — 159.2 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- adalimumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Extent of Exposure - Duration in Days |
159.2 | — |
| PRIMARY Total Number of Injections of Adalimumab |
2; 11.8 | — |
| PRIMARY Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections. |
98.85 | — |
| SECONDARY Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline). |
-0.17; -0.15; -0.15 | — |
| SECONDARY Overall Health Care Resource Utilization |
1.13; 0.17; 0.10; 0.60 | — |
| SECONDARY Employment Status: Number of Subjects Employed |
195; 199; 198; 192; 190; 208 | — |
| SECONDARY 50% Improvement in Draining Fistula Count and Fistula Healing |
35; 31; 32; 23; 27; 28 | — |
| SECONDARY Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment |
-22.08; -22.36; -29.93; -31.23; -28.49 | — |
| SECONDARY Hematology - Change From Baseline to Final Visit |
2.2; 0.011; 0.03; -30.2; -1.59; -2.005 | — |
| SECONDARY Clinical Chemistry - Change From Baseline to Final Visit |
0.6; 1.6; -5.2; 1.6; 1.7; 0.06 | — |
| SECONDARY Urinalysis - Change From Baseline to Final Visit |
0.02; -0.0004 | — |
| SECONDARY Work Productivity and Activity Impairment - Change From Baseline in Absenteeism |
-5.99; -7.55; -8.74; -8.54; -6.46 | — |
| SECONDARY Work Productivity and Activity Impairment - Change From Baseline in Presenteeism |
-20.58; -19.94; -25.79; -28.96; -26.69 | — |
| SECONDARY Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment |
-23.59; -24.79; -30.36; -34.00; -30.98 | — |
Summary
To make adalimumab available to subjects suffering from moderately to severely active Crohn's Disease (CD) and to expand the safety information on adalimumab. The study also assessed changes in Patient Reported Outcome Measures from baseline.
Eligibility Criteria
Inclusion Criteria
- Males or females 18 years of age and older
- Females: Not of childbearing potential OR Practicing approved birth control throughout the study and for 150 days after study completion
- Diagnosis of moderate to severe CD for greater than 16 weeks prior to screening; Crohn's Disease Activity Index score > 220 OR Harvey Bradshaw Index equal to or higher than 7, and who are refractory to optimal conventional therapies such as, 5-aminosalicylic acid (5-ASA), glucocorticoids, and immunosuppressive therapies (azathioprine, 6-MP and MTX)
- Subjects who failed prior infliximab therapy (as determined by the primary investigator), including those who never clinically responded ("primary non-responders")
Exclusion Criteria
- History of cancer other than some skin and cervical cancers
- History of opportunistic infections, central nervous system (CNS) demyelinating disease, chronic viral hepatitis, or untreated tuberculosis
- Subjects with other, poorly controlled medical conditions
- Subjects with any prior exposure to Tysabri® (natalizumab)
- Subjects who have received any investigational agent in the past 30 days or 5 half-lives prior to screening (whichever is longer)
- Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
Data sourced from ClinicalTrials.gov (NCT00427921). 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.