Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Ulcerative Colitis
NCT01494857 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2012-10-30
Summary
The purpose of this study is to assess the clinical benefit and tolerability of adalimumab, a fully human monoclonal antibody to tumor necrosis factor α (TNF- α), in patients with ulcerative colitis (UC) naive to treatment with biologics.
Conditions
Interventions
- DRUG
-
Adalimumab 40 mg from 4 to 1 injection once in two weeks. Total Treatment period - 10 weeks.
Sponsors & Collaborators
-
Clalit Health Services
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2013-12-31
- Completion
- 2013-12-31
Countries
- Israel
Study Locations
More Related Trials
-
Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
NCT02065622 ·Status: COMPLETED ·Phase: PHASE3
-
Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions
NCT02738125 ·Status: COMPLETED
-
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
NCT02163759 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
NCT00409617 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
NCT00853099 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon
NCT00348283 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab
NCT04183608 ·Status: RECRUITING ·Phase: PHASE4
-
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
NCT00409682 ·Status: COMPLETED ·Phase: PHASE3
-
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
NCT01550965 ·Status: COMPLETED ·Phase: PHASE3
-
Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD
NCT03059849 ·Status: WITHDRAWN ·Phase: PHASE4
-
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
NCT02171429 ·Status: COMPLETED ·Phase: PHASE3
-
Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
NCT00077779 ·Status: COMPLETED ·Phase: PHASE3
-
Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)
NCT00427921 ·Status: COMPLETED ·Phase: PHASE3
-
Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115
NCT02185014 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Outcome After Escalation and De-escalation of Adalimumab in Real Life in Ulcerative Colitis
NCT03142113 ·Status: COMPLETED
-
Remission in Subjects With Crohn's Disease, 1 Year Phase
NCT00055497 ·Status: COMPLETED ·Phase: PHASE3
-
Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
NCT00195715 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease
NCT02499783 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
NCT00105300 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Efficacy and Safety of AMT-101 in Combination With Adalimumab in Subjects With Ulcerative Colitis (MARKET)
NCT05372939 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis
NCT01671956 ·Status: TERMINATED ·Phase: PHASE2
-
A Prospective Non-interventional Multicenter Study to Evaluate the Effectiveness of Adalimumab in Korean Patients With Ulcerative Colitis (UC) and Identify Potential Predictors of Clinical Response in Routine Clinical Practice
NCT02499263 ·Status: COMPLETED
-
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
NCT03398148 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806
NCT00686374 ·Status: COMPLETED ·Phase: PHASE3
-
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
NCT02632175 ·Status: COMPLETED ·Phase: PHASE3