[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

+81-(0)3-6280-9600

Email address

contact_ea@eapharma.co.jp

Condition

Crohn's Disease

Treatment type

Interventional

Investigational product

E6011

Phase

Phase 2

Sponsor

Eisai Inc.

ClinicalTrials.gov identifier

NCT03733314

Study number

E6011-ET2

Understanding clinical trials

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About the study

The primary purpose of this study is to examine the efficacy and safety of E6011 after administration by means of double-blind placebo-controlled trial.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. administration) disease severity ranging from moderate to severe. CDAI score between 220 and 450, and a PRO2 score between 14 and 34. 3. With a SES-CD >= 7( or for participants with isolated ileal disease, >=4 in ileum
  2. segment) in the screening period, with one or more ulcers (in SES-CD score, ulcer presence subscore >=1 in any
  3. segment) assessed by colonoscopy and confirmed by a centralised review. 4. Who received adrenocorticosteroids or immunomodulators in the past, but showed no therapeutic response (insufficient
  4. response) or the drugs were not tolerated (intolerance). Alternatively, participants who cannot taper oral adrenocorticosteroids (dependence). Alternatively, participants who showed no therapeutic response after administering one biologic (primary nonresponse), participants who initially showed therapeutic response but it lessened or disappeared afterwards (secondary nonresponse), or participants who did not tolerate the drug (intolerance). 5. If the participants are taking aminosalicylic acid (5-ASA), salazosulfapyridine, or antibiotics for the treatment of Crohn's disease (metronidazole, ciprofloxacin, etc.), the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration. 6. If the participants are taking under 30 milligram per day (mg/
  5. day) of oral prednisolone (or equivalent
  6. adrenocorticosteroid) or 9 mg/day or less of oral budesonide, the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration. 7. If the participants are taking azathioprine (AZP), 6-mercaptopurine (6-
  7. MP) or methotrexate (MTX), the dosage and administration have not changed for at least 8 weeks prior to the start of the IMP administration.
Exclusion criteria

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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