E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study was to assess the efficacy and safety of adalimumab in Japanese subjects with moderately to severely active UC and to compare to the western studies. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this study was to assess the pharmacokinetics (PK) of
adalimumab following subcutaneous administration. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline.
•Active ulcerative colitis with a Mayo Score of 6-12 points at Baseline and endoscopy subscore of 2-3 during the Screening Period, despite concurrent treatment with at least one of the following (oral corticosteroids or immunosuppressants or both as defined below):
•Stable oral corticosteroid dose (prednisolone dose of ≥ 20 mg/day or equivalent) for at least 14 days prior to Baseline or stable oral corticosteroid dose (prednisolone of 5 to less than 20 mg/day) for at least 40 days prior to Baseline. And/or
•At least a consecutive 90-day course of azathioprine or 6-mercaptopurine (6-MP) prior to Baseline, with a dose of azathioprine ≥ 50 mg/day or 6-MP ≥ 30 mg/day, or a dose that was the highest tolerated by the patient.
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E.4 | Principal exclusion criteria |
•History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for ulcerative colitis or was planning bowel surgery.
•Patients with disease limited to the rectum.
•Indeterminate colitis and/or Crohn's disease.
•Received any biological therapy (including infliximab) in the past.
•History of tuberculosis or malignancy.
•Pregnant women.
•Patients with positive C. difficile stool assay at Screening.
•Current diagnosis of fulminant colitis and/or toxic megacolon. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Percentage of Participants With Clinical Remission at 8 Weeks
- Percentage of Participants With Clinical Remission at 52 Weeks |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
•Mayo Score [ Time Frame: Week 8 ]
•Mayo Score [ Time Frame: Week 52 ] |
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E.5.2 | Secondary end point(s) |
1. Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks
2. Percentage of Participants With a Clinical Response
3. Percentage of Participants With Mucosal Healing
4. Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1)
5. Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1)
6. Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1)
6. Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders
7. Number of Participants With Adverse Events up to Week 8
8. Number of Participants With Adverse Events up to Week 52
9. Number of Participants With Adverse Events During the Adalimumab Treatment Period |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Baseline and Weeks 8, 32, and 52
2. Baseline and Weeks 8, 32, and 52
3. Baseline and Weeks 8, 32, and 52
4. Baseline and Weeks 8, 32, and 52
5. Baseline and Weeks 8, 32, and 52
6. Baseline and Weeks 8, 32, and 52
7. Up to 8 weeks
8. Up to 52 weeks
9. 221 weeks |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |