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

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.

Conditions

Polymyalgia Rheumatica

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Polymyalgia Rheumatica
Intervention / Treatment

-

Contacts and Locations

Saint Clair Shores

Clinical Research Institute of Michigan LLC, Saint Clair Shores, Michigan, United States, 48081

San Antonio

Accurate Clinical Research Inc, San Antonio, Texas, United States, 78229

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * who have experienced a relapse during the treatment-free follow-up period of the core study, AND
  • * who have not been on rescue treatment.
  • * The participant would potentially derive benefit from secukinumab, and the benefit outweighs the risk, based on the investigator's judgement.
  • * Use of prohibited medications, as specified in the protocol
  • * History of ongoing, chronic or recurrent infectious disease (i.e., human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), active tuberculosis infection (TB))
  • * 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).
  • * Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zoster vaccines) within 6 weeks prior to Baseline
  • * Subjects whose participation in the extension study could expose them to an undue safety risk

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2028-02-10