RECRUITING

Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)

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Conditions

Polymyalgia RheumaticaPolymyalgia Rheumatica (PMR)secukinumabmonoclonal antibodysubcutaneous (s.c.)extensionlong-termsafetyREPLENISH

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica.

Official Title

A Multi-center, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Safety and Tolerability in Polymyalgia Rheumatica (PMR)

Quick Facts

Study Start:2024-06-28
Study Completion:2028-02-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06331312

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants who have completed 52-week Treatment Period as per protocol in a Novartis study of secukinumab in PMR patients (the "core study" - Study CAIN457C22301), AND
  2. * who have experienced a relapse during the treatment-free follow-up period of the core study, AND
  3. * who have not been on rescue treatment.
  4. * The participant would potentially derive benefit from secukinumab, and the benefit outweighs the risk, based on the investigator's judgement.
  1. * Use of prohibited medications, as specified in the protocol
  2. * History of ongoing, chronic or recurrent infectious disease (i.e., human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), active tuberculosis infection (TB))
  3. * History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
  4. * Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zoster vaccines) within 6 weeks prior to Baseline
  5. * Subjects whose participation in the extension study could expose them to an undue safety risk

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Clinical Research Institute of Michigan LLC
Saint Clair Shores, Michigan, 48081
United States
Accurate Clinical Research Inc
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-28
Study Completion Date2028-02-10

Study Record Updates

Study Start Date2024-06-28
Study Completion Date2028-02-10

Terms related to this study

Keywords Provided by Researchers

  • Polymyalgia Rheumatica (PMR)
  • secukinumab
  • monoclonal antibody
  • subcutaneous (s.c.)
  • extension
  • long-term
  • safety
  • REPLENISH

Additional Relevant MeSH Terms

  • Polymyalgia Rheumatica