[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

888-662-6728 (U.S. Only)

Email address

global-roche-genentech-trials@gene.com

Condition

Ulcerative Colitis

Treatment type

Interventional

Investigational product

Placebo

Phase

Phase 1

Sponsor

Hoffmann-La Roche

ClinicalTrials.gov identifier

NCT03943550

Study number

WP40161

Understanding clinical trials

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About the study

The principal aim of this study is to evaluate the safety and tolerability of RO7049665 in participants with active ulcerative colitis.

Who can take part?

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

Inclusion criteria

  1. Diagnosed with Ulcerative Colitis (UC) for at least 12 weeks prior to screening
  2. Screening colonoscopy for colorectal cancer conducted within the prior two years if a history of pancolitis with disease duration ≥ 8 years or history of left-sided colitis and disease duration ≥12 years
  3. Evidence of disease activity at time of screening
  4. Insufficient clinical response to standard of care (SOC) therapy or intolerance to SOC
Exclusion criteria

  1. Diagnosis of Crohn's disease or indeterminate colitis
  2. History of infection with hepatitis B, human immunodeficiency virus (HIV), active hepatitis C virus (HCV) infection, or other chronic infection
  3. Active infections requiring systemic therapy with antibiotic, antiviral or antifungal or febrile illness within 7 days before Day -1
  4. History of primary or acquired immunodeficiency

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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