[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

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

Find a Study Site

Study’s contact

Call center

1-833-445-3230 (GILEAD-0)

Email address

GileadClinicalTrials@gilead.com

Condition

Fistulizing Crohn's Disease

Treatment type

Interventional

Investigational product

Filgotinib

Phase

Phase 2

Sponsor

Gilead Sciences

ClinicalTrials.gov identifier

NCT03077412

Study number

GS-US-419-4016

Understanding clinical trials

Get answers to your questions about clinical trials.

About the study

The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24. Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.

Who can take part?

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

Inclusion criteria
  1. Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of screening visit
  2. Diagnosis of Crohn's disease (CD) with a minimum duration of CD of at least 3 months
  3. Has draining perianal fistulae as a complication of CD, confirmed by MRI at screening
  4. Previously demonstrated an inadequate clinical response, loss of response to, or intolerance of at least 1 of the following agents (depending on current country treatment recommendations/guidelines):
  5. Antibiotics AND/OR
  6. Immunomodulators AND/OR
  7. TNF╬▒ Antagonist
  8. Is willing and able to undergo MRI per protocol requirements
  9. Is willing and able to undergo flexible sigmoidoscopy per protocol requirements Key
Exclusion criteria
  1. Presence of current rectovaginal anovaginal or enterovesicular fistulae
  2. Presence of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
  3. History of total proctocolectomy, total colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study
  4. Use of any prohibited concomitant medications as described in the study protocol
  5. Active tuberculosis (TB) or history of latent TB that has not been treated Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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

Study locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to apply

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

Find a Study Site