Phase 3
Completed N=585
Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis
Source: ClinicalTrials.gov NCT00573794 ↗Enrolled (actual)
585
Serious AEs
26.7%
Results posted
Dec 2017
Primary outcomePrimary: Partial Mayo Score: Change From Baseline Over Time — 2.5; -0.2; -0.4; -0.5 units on a scale
◆ Published Evidence
Established
33citations · ~4 / year
Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis.
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).
Linked Publications
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Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Partial Mayo Score: Change From Baseline Over Time |
2.5; -0.2; -0.4; -0.5; -0.6; -0.8 | — |
| PRIMARY Mayo Score: Change From Baseline Over Time |
3.5; -0.3; -0.5; -0.8; -0.8; -1.0 | — |
| SECONDARY Percentage of Participants With Remission Per Partial Mayo Score Over Time |
52.4; 61.2; 69.3; 75.0; 74.7; 77.2 | — |
| SECONDARY Mayo Endoscopy Subscore: Change From Baseline Over Time |
1.1; -0.1; -0.1; -0.2; -0.3; -0.3 | — |
| SECONDARY Mayo Rectal Bleeding Subscore: Change From Baseline Over Time |
0.4; -0.1; -0.0; -0.1; -0.1; -0.2 | — |
| SECONDARY Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time |
0.8; -0.1; -0.2; -0.2; -0.2; -0.3 | — |
| SECONDARY Mayo Stool Frequency Subscore: Change From Baseline Over Time |
1.3; -0.1; -0.2; -0.2; -0.2; -0.3 | — |
| SECONDARY Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time |
176.0; 2.1; 4.7; 5.2; 7.6; 11.2 | — |
| SECONDARY 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time |
47.1; -0.7; 0.3; 0.0; 0.1; 0.7 | — |
| SECONDARY 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time |
49.3; 0.7; 1.2; 1.1; 1.3; 2.2 | — |
| SECONDARY Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time |
4.5; 1.6; -0.2; 0.9; 0.2; -1.1 | — |
| SECONDARY WPAI:GH Impairment While Working: Change From Baseline Over Time |
16.7; 1.1; -1.9; -0.2; -2.9; -4.0 | — |
| SECONDARY WPAI:GH Overall Work Impairment: Change From Baseline Over Time |
20.1; 1.2; -2.7; -0.8; -2.6; -5.0 | — |
| SECONDARY WPAI:GH Activity Impairment: Change From Baseline Over Time |
21.4; 1.1; -1.6; -0.7; -2.1; -3.4 | — |
| SECONDARY Colectomy Rate |
3.88 | — |
| SECONDARY Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations |
561; 43; 65; 435 | — |
| SECONDARY Number of Participants With Adverse Events |
496; 158 | — |
| SECONDARY Hematology: Mean Change From Baseline to Final Values in Hemoglobin |
-0.1 | — |
| SECONDARY Hematology: Mean Change From Baseline to Final Values in Hematocrit |
0.013 | — |
| SECONDARY 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 |
0.03; -10.5; 0.41; 0.164; 0.155; 0.051 | — |
| SECONDARY Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase |
3.7; 2.6; -0.2 | — |
| SECONDARY Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid |
-1.0; 2.4; 7.6 | — |
| SECONDARY Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides |
0.32; -0.003; -0.012; -0.0; 0.07; 0.05 | — |
| SECONDARY Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein |
-0.4; 0.7 | — |
| SECONDARY Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein |
0.382 | — |
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
Data sourced from ClinicalTrials.gov (NCT00573794) and the linked publication. 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.