[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

91 2266455645

Email address

clinical.trials@sparcmail.com

Condition

Active Psoriatic Arthritis

Treatment type

Interventional

Investigational product

TILD

Phase

Phase 3

Sponsor

Sun Pharma Global FZE

ClinicalTrials.gov identifier

NCT04314544

Study number

TILD-19-07

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About the study

This is a multicenter Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1)

Who can take part?

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

Inclusion criteria
  1. s) use for the treatment of PsO or PsA.
Exclusion criteria
  1. 1) oral contraceptive, depo progesterone, or intrauterine device; and (
  2. 2) a barrier method (condom or diaphragm). Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (e.g.,
  3. condom) if not surgically sterile (i.e., vasectomy). Contraceptive methods must be practiced upon entering the study and through 16 weeks after the last dose of IMP. If a subject discontinues prematurely, the contraceptive method must be practiced for 16 weeks following final administration of IMP. A FSH test should be performed to confirm menopause for those women with no menses for less than 1 year. 9. Subject currently enrolled in another investigational device/procedure or drug study, or Baseline of this study is less than 30 days or 5 half-lives (whichever is
  4. longer) since ending another investigational device/procedure or drug study(s), or receiving other investigational agent(s). 10. Subject previously has been enrolled (
  5. randomized) in this study. 11. Subject has any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures. 12. Donation or loss of 400 mL or more of blood within 8 weeks before dosing. 13. Subjects who have been placed in an institution on official or judicial orders. 14. Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest could arise.

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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