[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

+91-79-23969100

Email address

shohinighosh@torrentpharma.com

Condition

Diabetes,Dyslipidemias,Hypertension

Treatment type

Interventional

Investigational product

Placebo

Phase

Phase 3

Sponsor

Torrent Pharmaceuticals Limited

ClinicalTrials.gov identifier

NCT03254446

Study number

CT/P015/CMR/16/03_01

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About the study

The phase III trial is designed with an aim of determining the efficacy of Investigational Product TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e., HbA1c, MAP and non-HDL cholesterol. This study will be a randomized, double blind, parallel group, placebo controlled, multi-centre, multinational study in 1250 subjects. All the study subjects will receive once daily dose of TRC150094 45 mg or placebo tablets in addition to their standard of care, for 24 weeks followed by roll over to a safety extension phase of 26 weeks.

Who can take part?

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

Inclusion criteria
  1. inclusive) 2. BMI in the range 23-39 (
  2. inclusive) kg/m2 3. HbA1C ≥7.5 % 4. Stable therapy of ≤2 oral hypoglycemic agents for at least two months prior to screening at doses that are appropriate for the duration of the study in the judgment of the investigator. 5. Non HDL-cholesterol ≥ 160 mg/dL. 6. Mean Arterial Pressure (
  3. MAP) ≥100 mm Hg based on average of 24 hours' ambulatory blood pressure monitoring (
  4. ABPM) with or without antihypertensive treatment (subjects will have to be on stable dose of anti-hypertensive treatment for at least two months prior to screening); Dose should be appropriate for the duration of the study in the judgment of the investigator. 7. Willing to give written informed consent 8. Ability to adhere to the study restrictions and assessments schedule
Exclusion criteria
  1. SGLT2) inhibitors. 6. Acute coronary syndrome (
  2. ACS) or stroke or any revascularization within last 6 months. 7. Subjects having untreated thyroid dysfunction (TSH <0.3 or >5.5 µIU/
  3. mL) or hormone related obesity disorder. 8. Subjects with liver enzymes (SGOT,
  4. SGPT) more than 3X of upper limit of normal value. 9. eGFR <30 mL/min as evaluated by Modification of Diet in Renal Disease (
  5. MDRD) method. 10. Seropositive for HIV, Hepatitis B or Hepatitis C. 11. History of alcohol or drug abuse, psychiatric disorder, any bleeding disorder, malignancy in last 3 years. 12. Pregnant or lactating women. 13. Female of childbearing potential, who are neither surgically sterilized nor willing to use reliable contraceptive methods (double barrier methods or intrauterine device). 14. Male subjects with partners of childbearing potential not willing to use reliable contraception methods. 15. Clinically significant abnormal physical findings, laboratory results, ECG findings and/or any other clinical observation or history during the screening examination, which would interfere with the objectives of the study. 16. Intake of any investigational drug within 3 months prior to the first dose of study drug. 17. In the opinion of the investigator, subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures, keep appointments, or plan to relocate during the study.

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.

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