Phase ll Study of Postoperative Adalimumab Maintenance Therapy for Crohn's Disease Recurrence

Phase ll Study of Postoperative Adalimumab Maintenance Therapy for Crohn's Disease Recurrence - PAD study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007514

Enrollment

Registered

2012-03-15

Start date

2012-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn&#39

Interventions

Adalimumab (HUMIRA 40mg for SC Injection) Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Clinically and histopathologically confirmed Crohn's disease (2) Patients who underwent enterectomy and/or enteroanastomosis for primary intestinal lesions (stenosis, fistulae, abscess). (3) Prior therapies are no object. (4) Written informed concent (5) Adequate organ function

Exclusion criteria

Exclusion criteria: (1) Uncontrolled infection (2) Confirmed opportunistic infection diseases within 6 months (3) Tuberculosis or a history of it (4) most positive tuberculin skin test (5) Active hepatitis B, C or a history of hepatitis C (6) Confirmed HIV infection (7) Demyelinating disease or a history of it (8) History of lymphoproliferative disorder, or suspicion of lymphoproliferative disorder or splenomegaly (9) Lupus syndrome, and positive anti-dsDNA antibody (10) malignant tumor (11) Clinically abnormal electrocardiogram or cardiovascular disease. (12) Severe pulmonary disease (13) Interstitial pneumonia or pulmonary fibrosis or a history of those (14) Severe hepatic disease (15) Severe renal failure (16) Severe drug allergies (17) Bowel obstraction or bowel paresis (18) Severe or uncontrollable complications (diabetes mellitus, hypertention, diarrhea, electrolyte abnormality, etc.) (19) Psychiatric disorder, central nervous system damage, cerebrovascular diseases (20) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (21) Not appropriate for the study at the physician's assessment.

Design outcomes

Primary

Measure	Time frame
Endoscopic recurrence rete at the anastomotic site after 1 year.	—

Secondary

Measure	Time frame
Endoscopic recurrence rete at the anastomotic site Clinical Recurrence rate Crohn's disease activity index point (CDAI) Recurrence-free survival time. Time to treatment failure. Rate of adverse event	—

Countries

Japan

Contacts

Public ContactNorifumi Hattori

Nagoya University Gradeate School of Medicine Department of Gastroenterology

norifumi@med.nagoya-u.ac.jp(81)52-744-2250

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

Phase ll Study of Postoperative Adalimumab Maintenance Therapy for Crohn&#39;s Disease Recurrence