[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

1-800-718-1021

Email address

ClinicalTrials.gov_Inquiries@pfizer.com

Condition

Ulcerative Colitis

Treatment type

Interventional

Investigational product

PF-07054894

Phase

Phase 1

Sponsor

Pfizer

ClinicalTrials.gov identifier

NCT05549323

Study number

C4151002

Understanding clinical trials

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About the study

This is a study to learn if the experimental medicine (called PF-07054894) is safe, effective, and how it is processed in adult people with ulcers in the colon.

Who can take part?

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

Inclusion criteria

  1. Confirmed diagnosis of moderate to severe UC for ≥3 months prior to baseline.
  2. Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy).
  3. Must have a 5 to 9 score on the modified mayo score, including an endoscopy subscore of at least 2.
  4. Must inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.
  5. Total body weight >40 kg (88.2 lb).
Exclusion criteria

  1. Presence of indeterminate; microscopic; ischemic; infectious; radiation colitis; diverticular disease; Crohn's disease; colonic stricture; colonic obstruction/ resection; presence of cancer.
  2. History of bowel surgery within 6 months prior to baseline.
  3. History of significant trauma or major surgery within 4 weeks of screening or considered in imminent need of surgery or with elective surgery scheduled to occur during the study.
  4. Presence of clinical signs of fulminant colitis or toxic megacolon, primary sclerosing cholangitis and evidence of colonic dysplasia, adenomas or neoplasia.
  5. Clinically significant infections within 6 months of baseline

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

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site