Clinical trial NCT00573794: Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis
Official title: A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2007-12-14
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis who participated in and successfully completed M06-826 (NCT00385736) or M06-827 (NCT00408629).


Eligibility criteria: Inclusion Criteria:

* Subject must have successfully enrolled and completed either study M06-826 (NCT00385736) or study M06-827 (NCT00408629)
* Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria:

* Subject has not responded to weekly adalimumab therapy in M06-826 (NCT00385736) or M06-827 (NCT00408629)
* Subject considered by the investigator, for any reason, to be an unsuitable candidate
* Female subject who is pregnant or breast-feeding or considering becoming pregnant

Primary outcomes:
measure: Partial Mayo Score: Change From Baseline Over Time
timeFrame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
measure: Mayo Score: Change From Baseline Over Time
timeFrame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Secondary outcomes:
measure: Percentage of Participants With Remission Per Partial Mayo Score Over Time
timeFrame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
measure: Mayo Endoscopy Subscore: Change From Baseline Over Time
timeFrame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
measure: Mayo Rectal Bleeding Subscore: Change From Baseline Over Time
timeFrame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
measure: Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time
timeFrame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
measure: Mayo Stool Frequency Subscore: Change From Baseline Over Time
timeFrame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
measure: Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time
timeFrame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
measure: 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time
timeFrame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
measure: 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time
timeFrame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
measure: Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time
timeFrame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
measure: WPAI:GH Impairment While Working: Change From Baseline Over Time
timeFrame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
measure: WPAI:GH Overall Work Impairment: Change From Baseline Over Time
timeFrame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
measure: WPAI:GH Activity Impairment: Change From Baseline Over Time
timeFrame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
measure: Colectomy Rate
timeFrame: 5 years
measure: Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations
timeFrame: 5 years
measure: Number of Participants With Adverse Events
timeFrame: From first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks)
measure: Hematology: Mean Change From Baseline to Final Values in Hemoglobin
timeFrame: Baseline (Week 0), final value (up to 5 years)
measure: Hematology: Mean Change From Baseline to Final Values in Hematocrit
timeFrame: Baseline (Week 0), final value (up to 5 years)
measure: Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils
timeFrame: Baseline (Week 0), final value (up to 5 years)
measure: Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase
timeFrame: Baseline (Week 0), final value (up to 5 years)
measure: Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid
timeFrame: Baseline (Week 0), final value (up to 5 years)
measure: Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides
timeFrame: Baseline (Week 0), final value (up to 5 years)
measure: Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein
timeFrame: Baseline (Week 0), final value (up to 5 years)
measure: Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein
timeFrame: Baseline (Week 0), final value (up to 5 years)
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc
role: STUDY_DIRECTOR
References:
citation: Colombel JF, Sandborn WJ, Ghosh S, Wolf DC, Panaccione R, Feagan B, Reinisch W, Robinson AM, Lazar A, Kron M, Huang B, Skup M, Thakkar RB. Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: Data from ULTRA 1, 2, and 3. Am J Gastroenterol. 2014 Nov;109(11):1771-80. doi: 10.1038/ajg.2014.242. Epub 2014 Aug 26.
citation: Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.