[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.

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Study’s contact

Call center

+44 (0)1223 837650

Email address

info@vhsquared.com

Condition

Crohn's Disease

Treatment type

Interventional

Investigational product

Placebo

Phase

Phase 2

Sponsor

VHsquared Ltd.

ClinicalTrials.gov identifier

NCT02976129

Study number

V56502

Understanding clinical trials

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About the study

The purpose of this study is to evaluate the efficacy and safety of V565 in participants with active Crohn's Disease.

Who can take part?

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

Inclusion criteria
  1. History of Crohn's Disease of at least 3 months duration prior to screening
  2. CDAI score of ≥220 to ≤450 during screening
  3. CRP ≥5 mg/L (or, if CRP is normal, FCP ≥250 µg/g) at screening
  4. Permitted CD medication regimen expected to remain stable during the period of the study
Exclusion criteria
  1. Previous lack of response or current contra-indication to an anti-TNFα agent
  2. Certain complications of Crohn's Disease that would make it hard to assess response to study drug
  3. Known history or suspicion of IBD other than Crohn's disease
  4. History of TB or latent TB infection that has not been treated
  5. Any significant illness or condition which would preclude effective participation in the study
  6. GI infection as demonstrated by presence of enteric pathogens
  7. Pregnant or lactating women
  8. Abdominal surgery in the previous 6 months
  9. Unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject's safety or confound data interpretation

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