Phase 3
Completed N=952
Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
Ulcerative Colitis (UC)
Source: ClinicalTrials.gov NCT02065622 ↗
Enrolled (actual)
952
Serious AEs
8.0%
Results posted
Oct 2020
Primary outcomePrimary: Induction Period Primary Endpoint: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 8 — 10.9; 13.3; 11.6; 13.8 percentage of participants — p=0.269
◆ Published Evidence
Established
20citations · ~4 / year
Higher adalimumab maintenance regimen is more effective than standard dose in anti-TNF experienced Crohn's disease patients.
Summary
To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.
Linked Publications (4)
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Higher adalimumab maintenance regimen is more effective than standard dose in anti-TNF experienced Crohn's disease patients.
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Baseline TREM-1 Whole Blood Gene Expression Does Not Predict Response to Adalimumab Treatment in Patients with Ulcerative Colitis or Crohn's Disease in the SERENE Studies.
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HLA-DQA1*05 Associates With Anti-Tumor Necrosis Factor Immunogenicity and Low Adalimumab Trough Concentrations in Inflammatory Bowel Disease Patients From the SERENE Ulcerative Colitis and Crohn's Disease Studies.
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Assessing the Impact of Immunogenicity and Improving Prediction of Trough Concentrations: Population Pharmacokinetic Modeling of Adalimumab in Patients with Crohn's Disease and Ulcerative Colitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Induction Period Primary Endpoint: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 8 |
10.9; 13.3; 11.6; 13.8 | 0.269 |
| PRIMARY Maintenance Period Primary Endpoint: Percentage of Week 8 Responders (Per FMS) With Clinical Remission (Per FMS) at Week 52 |
29.0; 39.5; 30.1; 41.1 | 0.069 |
| SECONDARY Induction Period Ranked Secondary Endpoint 1: Percentage of Participants With Endoscopic Improvement at Week 8 |
27.1; 31.1; 26.9; 30.5 | 0.181 |
| SECONDARY Induction Period Ranked Secondary Endpoint 2: Percentage of Participants With Fecal Calprotectin < 150 mg/kg at Week 8 |
27.1; 31.1; 26.9; 30.5 | 0.300 |
| SECONDARY Induction Period Ranked Secondary Endpoint 3: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Response (Increase of IBDQ ≥ 16 From Baseline) at Week 8 |
60.9; 67.2; 60.7; 65.3 | 0.050 |
| SECONDARY Induction Period Ranked Secondary Endpoint 4: Percentage of Participants With Clinical Response Per FMS at Week 8 |
40.0; 47.1; 38.8; 47.3 | 0.035 sig |
| SECONDARY Induction Period Ranked Secondary Endpoint 5: Percentage of Participants With Endoscopic Remission at Week 8 |
10.0; 13.1; 10.0; 12.9 | 0.160 |
| SECONDARY Induction Period Ranked Secondary Endpoint 6: Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 8 |
63.2; 71.3; 63.1; 69.8 | 0.011 sig |
| SECONDARY Induction Period Ranked Secondary Endpoint 7: Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 8 |
57.1; 61.1; 57.5; 59.9 | 0.218 |
| SECONDARY Maintenance Period Ranked Secondary Endpoint 1: Percentage of Week 8 Responders (Per FMS) With Endoscopic Improvement at Week 52 |
41.4; 51.3; 41.7; 52.0 | 0.098 |
| SECONDARY Maintenance Period Ranked Secondary Endpoint 2: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52 |
53.3; 74.7; 54.4; 74.1 | 0.002 sig |
| SECONDARY Maintenance Period Ranked Secondary Endpoint 3: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission at Week 52 |
27.2; 38.9; 28.2; 39.8 | 0.093 |
| SECONDARY Maintenance Period Ranked Secondary Endpoint 4: Percentage of Week 8 Remitters (Per FMS) With Clinical Remission (Per FMS) at Week 52 |
40.5; 57.1; 44.4; 55.8 | 0.161 |
| SECONDARY Maintenance Period Ranked Secondary Endpoint 5: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Improvement at Week 52 |
51.4; 64.3; 55.6; 61.5 | 0.272 |
| SECONDARY Maintenance Period Ranked Secondary Endpoint 6: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52 |
53.8; 77.8; 56.3; 71.4 | 0.074 |
| SECONDARY Maintenance Period Ranked Secondary Endpoint 7: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission (Per FMS) at Week 52 |
34.6; 55.6; 37.5; 51.4 | 0.151 |
| SECONDARY Maintenance Period Ranked Secondary Endpoint 8: Percentage of Week 8 Responders (Per FMS) With IBDQ Response (Increase of IBDQ ≥ 16 From Baseline) at Week 52 |
62.1; 66.4; 62.6; 65.7 | 0.422 |
| SECONDARY Maintenance Period Ranked Secondary Endpoint 9: Percentage of Week 8 Non-Responders With Clinical Remission (Per FMS) at Week 52 |
12.1; 15.8; 12.1; 16.0 | 0.351 |
| SECONDARY Maintenance Period Ranked Secondary Endpoint 10: Percentage of Week 8 Non-Remitters With Clinical Remission (Per FMS) at Week 52 |
17.4; 22.9; 17.0; 23.8 | 0.121 |
| SECONDARY Maintenance Period Ranked Secondary Endpoint 11: Percentage of Week 8 Responders (Per FMS) With Endoscopic Subscore of 0 at Week 52 |
27.6; 35.5; 27.0; 35.4 | 0.159 |
| SECONDARY Maintenance Period Ranked Secondary Endpoint 12: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Subscore of 0 at Week 52 |
45.9; 47.6; 42.2; 44.2 | 0.903 |
| SECONDARY Maintenance Period Ranked Secondary Endpoint 13: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Bowel Symptom Domain at Week 52 |
62.1; 69.7; 62.6; 71.4 | 0.160 |
| SECONDARY Maintenance Period Ranked Secondary Endpoint 14: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Fatigue Item at Week 52 |
53.8; 61.2; 55.2; 59.4 | 0.207 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy during Screening period.
- Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite concurrent or prior treatment with a full and adequate course, in the opinion of the Investigator, with oral corticosteroids or immunosuppressants or both. Mayo Score is confirmed by central reader.
Exclusion Criteria
- Subject with Crohn's disease (CD) or indeterminate colitis (IC).
- Current diagnosis of fulminant colitis and/or toxic megacolon.
- Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
- Chronic recurring infections or active tuberculosis (TB).
Data sourced from ClinicalTrials.gov (NCT02065622) 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.