[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

+1 855-218-9153

Email address

ct.gov@arenapharm.com

Condition

Ulcerative Colitis

Treatment type

Interventional

Investigational product

Etrasimod

Phase

Phase 3

Sponsor

Pfizer

ClinicalTrials.gov identifier

NCT03950232

Study number

APD334-303

Understanding clinical trials

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About the study

The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).

Who can take part?

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

Inclusion criteria

  1. Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies and meet the following additional criteria:
  2. Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837) must have completed the Week 12 visit and have been assessed to have active UC that has not improved or has worsened from baseline or completed the Week 52 visit
  3. Participants previously enrolled in APD334-302 (NCT03996369) must have completed the Week 12 visit
Exclusion criteria

  1. If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
  2. Experienced an adverse event that led to discontinuation from parent study

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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Find a Study Site