Phase 3
Completed N=777
Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
Source: ClinicalTrials.gov NCT00195715 ↗Enrolled (actual)
777
Serious AEs
38.1%
Results posted
Jan 2010
Primary outcomePrimary: Percentage of Subjects Achieving Clinical Remission — 69.5 Percentage of participants
Summary
To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Achieving Clinical Remission |
46.7 | — |
| SECONDARY Percentage of Subjects Achieving Clinical Remission |
46.7 | — |
| SECONDARY Percentage of Subjects Achieving Clinical Response 100 (CR-100) |
85.7 | — |
| SECONDARY Percentage of Subjects Achieving Clinical Response 70 (CR-70) |
91.2 | — |
| SECONDARY Percentage of Subjects Achieving Steroid-free Clinical Remission |
63.1 | — |
| SECONDARY Percentage of Subjects Achieving Steroid-free CR-100 |
74.8 | — |
| SECONDARY Percentage of Subjects With Fistula Remission |
55.8 | — |
| SECONDARY Percentage of Subjects With Infection |
80.2 | — |
| SECONDARY Percentage of Subjects With Serious Infection |
10.6 | — |
| SECONDARY Percentage of Subjects With Malignancy |
4.1 | — |
| SECONDARY Percentage of Subjects With Lymphoma |
0.1 | — |
| SECONDARY Percentage of Subjects With Nonmelanoma Skin Cancer |
1.8 | — |
| SECONDARY Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma) |
2.3 | — |
| SECONDARY Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer) |
2.4 | — |
| SECONDARY Percentage of Subjects With Injection Site Reaction-related Adverse Event |
22.8 | — |
| SECONDARY Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis) |
4.9 | — |
| SECONDARY Percentage of Subjects With Congestive Heart Failure |
— | — |
| SECONDARY Percentage of Subjects With Demyelinating Disease |
0.3 | — |
| SECONDARY Percentage of Subjects With Hepatic-related Adverse Event |
8.1 | — |
| SECONDARY Percentage of Subjects With Allergic Reaction-related Adverse Event |
2.7 | — |
| SECONDARY Percentage of Subjects With Lupus-like Syndrome |
0.4 | — |
| SECONDARY Percentage of Subjects With Hematologic-related Adverse Event |
1.5 | — |
| SECONDARY Percentage of Subjects With Fatal Adverse Event |
0.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must have successfully completed either the M02-404 (NCT00077779) or M04-691 (NCT00105300) protocol to be eligible for this study
- Diagnosis of Crohn's disease
- Willing and able to give informed consent
Exclusion Criteria
- Diagnosis of ulcerative colitis
- Women cannot be pregnant or breastfeeding
- Previous history of listeria infection or untreated tuberculosis
- Previous history of cancer other than successfully treated skin cancer or carcinoma-in-situ of the cervix
Data sourced from ClinicalTrials.gov (NCT00195715). 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. Informational only — not medical advice.