Phase 3
Completed N=28
A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease
Source: ClinicalTrials.gov NCT01958827 ↗Enrolled (actual)
28
Serious AEs
28.6%
Results posted
Apr 2016
Primary outcomePrimary: Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8 — 75 percentage of participants
◆ Published Evidence
Emerging
13citations · ~2 / year
Efficacy and Safety of Dose Escalation to Adalimumab 80 mg Every Other Week in Japanese Patients with Crohn's Disease Who Lost Response to Maintenance Therapy.
Summary
The purpose of this study is to investigate the efficacy, safety and pharmacokinetics after dose escalation in Japanese subjects with Crohn's Disease.
Linked Publications
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Efficacy and Safety of Dose Escalation to Adalimumab 80 mg Every Other Week in Japanese Patients with Crohn's Disease Who Lost Response to Maintenance Therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8 |
75 | — |
| SECONDARY Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52 |
14.3; 25.0; 28.6; 32.1; 35.7; 42.9 | — |
| SECONDARY Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52 |
67.9; 67.9; 67.9; 67.9; 71.4; 64.3 | — |
| SECONDARY Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52 |
46.4; 57.1; 64.3; 64.3; 64.3; 67.9 | — |
| SECONDARY Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52 |
32.1; 35.7; 39.3; 46.4; 50.0; 50.0 | — |
| SECONDARY C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52 |
-0.570; -0.426; -0.710; -0.923; -0.907; -0.813 | — |
| SECONDARY Number of Participants With Potentially Significant Hematology Parameters |
1; 0; 0; 0; 0; 4 | — |
| SECONDARY Number of Participants With Potentially Significant Clinical Chemistry Parameters |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit |
-3.9; -2.5; -1.1; -1.3; -0.2; 1.9 | — |
| SECONDARY Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit |
-0.6; 0.2; 0.7; 1.1; 0.1; 0.8 | — |
| SECONDARY Heart Rate: Mean Change From Baseline (Week 0) to Each Visit |
-0.3; 0.7; -1.1; -1.1; -1.9; -3.0 | — |
| SECONDARY Body Temperature: Mean Change From Baseline (Week 0) to Each Visit |
-0.03; -0.02; -0.08; -0.14; -0.11; -0.16 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
24; 5; 2; 8; 4; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subject ≥ 15 years of age at the time of informed consent.
- Subject with Crohn's disease who received induction treatment of commercially available Humira® (160 mg initially and 80 mg at 2 weeks after initial dose), achieved response after initial dose, and then lost response during maintenance treatment with Humira®.
- Subject with elevated C-reactive Protein (CRP) at Screening.
- If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after the last dose of study drug.
- Subject has a negative tuberculosis (TB) screening assessment. If the subject has evidence of a latent TB infection; the subject must initiate and complete a minimum of 21 days of an ongoing TB prophylaxis (in such case, screening period can be prolonged until 21 days past after initiation of prophylaxis and study drug is administered) or have documented completion of a full course of TB prophylaxis, prior to Week 0.
Exclusion Criteria
- Subject with suspicion of colitis other than Crohn's disease.
- Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).
- Subject with abscess or suspicion of abscess, or subject with infection(s).
Data sourced from ClinicalTrials.gov (NCT01958827) 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.