[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

please email:

Email address

Clinical.Trials@bms.com

Condition

Psoriatic Arthritis

Treatment type

Interventional

Investigational product

Apremilast

Phase

Phase 3

Sponsor

Bristol-Myers Squibb

ClinicalTrials.gov identifier

NCT04908189

Study number

IM011055

Understanding clinical trials

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About the study

The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy information.

Who can take part?

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

Inclusion criteria

  1. Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at Screening
  2. Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening
  3. Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at Screening
  4. Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and Day 1
  5. Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening
  6. Must have completed the week 52 treatment for the optional open-label long-term extension period
Exclusion criteria

  1. Nonplaque psoriasis at Screening or Day 1
  2. Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis
  3. History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease)
  4. Active fibromyalgia
  5. Received an approved or investigational biologic therapy for the treatment of PsA or PsO Other protocol-defined inclusion/exclusion criteria apply

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