[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

only use E-mail

Email address

edrdimdisclosure@chugai-pharm.co.jp

Condition

Postmenopausal Osteoporosis

Treatment type

Observational

Investigational product

Eldecalcitol soft capsules

Sponsor

Chugai Pharmaceutical

ClinicalTrials.gov identifier

NCT05433207

Study number

EDR2201CN

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About the study

This is a post-marketing drug intensive monitoring surveillance with an observational, non-interventional design. The objectives are to compare the incidence of hypercalcemia in patients with and without calcium intake (including dietary supplements, excepting calcium from meals), and to monitor the type, incidence, severity, and relevance of other adverse drug reactions,including urolithiasis.

Who can take part?

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

Inclusion criteria

  1. Postmenopausal osteoporosis patients who signed the informed consent form and are expected to receive Edirol during the intensive monitoring period.
  2. Patients with postmenopausal osteoporosis
  3. Patients who signed the informed consent form
  4. Patients who are expected to receive Edirol during planned enrollment period
Exclusion criteria

  1. Exclude if any of the following:
  2. Men
  3. No osteoporosis
  4. Other osteoporosis (not postmenopausal)
  5. Started Edirol before ICF signature
  6. Did not sign ICF

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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Find a Study Site