Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease -OASISstudy

Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease -OASISstudy - Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease -OASISstudy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010524

Enrollment

Registered

2013-04-17

Start date

2013-03-29

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

Adalimubab is administered continuously starting with 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards. Continous administration of azathioprine concomitantly with adalimubab at the in

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with active Crohn's disease (CDA I of at least 150) on infliximab treatment (5-10 mg/kg/4-8 weeks), but without a history of adalimubab use.

Exclusion criteria

Exclusion criteria: (1)Adalimumab contraindication 1)Patients with severe infection (Sepsis, etc) 2)Patients with active tuberculosis 3)Patients with history of hypersensitivity to any of the other ingredients of Adalimumab 4)Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease 5)Patients with congestive heart failure (2)Azathioprine contraindication 1)Patients with history of hypersensitivity to any of the other ingredients of Azathioprine 2)Patients with the number of leukocytes below 3000/mm3 3)Pregnant or likely to be pregnant women (3)Lactating women (4)Patients < 15 years of age (5)Patients not approving the study consent (6)Patients who have received immunomodulators like Azathioprine, 6-mercaptopurine, Tacrolimus and Methotrexate within 8 weeks. (7)Patients with malignancy (8)Patients in 3 months after gastrointestinal surgery (9)Patients with short bowel syndrome or an artificial anus (10)Patient has an imminent CD-related surgery (11)Patients judged as inadequate at the discretion of physicians

Design outcomes

Primary

Measure	Time frame
Amount of change in CDI from baseline to 24 hr post-treatment by status of azathioprine concomitant use. Plasma adalimubab concentration at 24 weeks by status of azathioprine concomitant use.	—

Secondary

Measure	Time frame
CDAI and remission achievement rate at each evaluation time by status of azathioprine concomitant use. (Remission:below CDAI150) AAA positive rate at 24 weeks by status of azathioprine concomitant use Changes in endoscopic findings(SES-CD) before and at 24 weeks of treatment by status of azathioprine concomitant use CRP at each evaluation time by status of azathioprine concomitant use AAA positive rate at 24 weeks by status of ATI before treatment Remission achievement rate at each evaluation time by status of ATI Adverse events etc.	—

Measure

Time frame

CDAI and remission achievement rate at each evaluation time by status of azathioprine concomitant use. (Remission:below CDAI150) AAA positive rate at 24 weeks by status of azathioprine concomitant use Changes in endoscopic findings(SES-CD) before and at 24 weeks of treatment by status of azathioprine concomitant use CRP at each evaluation time by status of azathioprine concomitant use AAA positive rate at 24 weeks by status of ATI before treatment Remission achievement rate at each evaluation time by status of ATI Adverse events etc.

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Countries

Japan

Contacts

Public ContactMasakazu Nagahori

Tokyo Medical & Dental University Gastroenterology

nagahori.gast@tmd.ac.jp03-5803-5877

Outcome results

None listed

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

Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn&#39;s disease -OASISstudy