Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
- Conditions
- Crohn's Disease
- Registration Number
- NCT00195715
- Lead Sponsor
- Abbott
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 777
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Percentage of Subjects Achieving Clinical Remission Week 156 Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
- Secondary Outcome Measures
Name Time Method Percentage of Subjects Achieving Clinical Remission Week 204 Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
Percentage of Subjects Achieving Clinical Response 100 (CR-100) Week 156 A CR-100 is a decrease from baseline in CDAI score of 100 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
Percentage of Subjects Achieving Clinical Response 70 (CR-70) Week 156 A CR-70 is a decrease from baseline in CDAI score of 70 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
Percentage of Subjects Achieving Steroid-free Clinical Remission Week 156 Steroid-free remission was achieved if the subject stopped taking steroids before the visit and had a Crohn's Disease Activity Index (CDAI) score of \<150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
Percentage of Subjects Achieving Steroid-free CR-100 Week 156 Steroid-free CR-100 was achieved if the subject stopped taking steroids before the visit and had a decrease from baseline in CDAI score of 100 or more points at that visit. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
Percentage of Subjects With Fistula Remission Week 156 Fistula remission was defined as the absence of draining fistulas in subjects with fistula present at the preceding study's baseline visit.
Percentage of Subjects With Infection Up to 262 weeks of adalimumab treatment Percentage of Subjects With Serious Infection Up to 262 weeks of adalimumab treatment Serious infections are infectious adverse events that meet at least one criterion for a serious adverse event (e.g., death, life threatening event, hospitalization) including tuberculosis (TB), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis), and infections due to other opportunistic pathogens.
Percentage of Subjects With Malignancy Up to 262 weeks of adalimumab treatment Percentage of Subjects With Lymphoma Up to 262 weeks of adalimumab treatment Percentage of Subjects With Nonmelanoma Skin Cancer Up to 262 weeks of adalimumab treatment Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma) Up to 262 weeks of adalimumab treatment Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer) Up to 262 weeks of adalimumab treatment Percentage of Subjects With Injection Site Reaction-related Adverse Event Up to 262 weeks of adalimumab treatment An injection site reaction is any adverse event corresponding to a preferred term beginning with "injection site" excluding injection site arthritis, injection site movement impairment, injection site photosensitivity, injection site joint effusion, injection site joint inflammation, injection site scab, injection site joint pain, or injection site laceration.
Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis) Up to 262 weeks of adalimumab treatment Percentage of Subjects With Congestive Heart Failure Up to 262 weeks of adalimumab treatment Percentage of Subjects With Demyelinating Disease Up to 262 weeks of adalimumab treatment Percentage of Subjects With Hepatic-related Adverse Event Up to 262 weeks of adalimumab treatment Percentage of Subjects With Allergic Reaction-related Adverse Event Up to 262 weeks of adalimumab treatment Percentage of Subjects With Lupus-like Syndrome Up to 262 weeks of adalimumab treatment Percentage of Subjects With Hematologic-related Adverse Event Up to 262 weeks of adalimumab treatment Percentage of Subjects With Fatal Adverse Event Up to 262 weeks of adalimumab treatment
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Trial Locations
- Locations (111)
Site Ref # / Investigator 1894
🇺🇸Huntsville, Alabama, United States
Site Ref # / Investigator 1895
🇺🇸Jacksonville, Alabama, United States
Site Ref # / Investigator 1787
🇺🇸La Jolla, California, United States
Site Ref # / Investigator 1902
🇺🇸Roseville, California, United States
Site Ref # / Investigator 1824
🇺🇸San Diego, California, United States
Site Ref # / Investigator 1891
🇺🇸San Diego, California, United States
Site Ref # / Investigator 1860
🇺🇸Englewood, Colorado, United States
Site Ref # / Investigator 6178
🇺🇸Lone Tree, Colorado, United States
Site Ref # / Investigator 1904
🇺🇸Wheat Ridge, Colorado, United States
Site Ref # / Investigator 1858
🇺🇸Bridgeport, Connecticut, United States
Scroll for more (101 remaining)Site Ref # / Investigator 1894🇺🇸Huntsville, Alabama, United States