Authorised Therapeutic confirmatory (Phase III) Polymyalgia Rheumatica

A multi-center, open-label extension study of subcutaneous secukinumab to evaluate the long-term safety and tolerability in polymyalgia rheumatica (PMR)

EU CTIS ID: 2023-508077-85-00

What this study is testing

To evaluate long-term safety as assessed by occurrence of adverse events/serious adverse events (AEs/SAEs)

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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. Relapse is defined as recurrence of symptoms of PMR or as detection of signs and symptoms of a new-onset GCA that requires an increase of GC dose, re-initiation of GC treatment, or other changes in treatment of PMR.
  • The participant would potentially derive benefit from secukinumab, and the benefit outweighs the risk, based on the investigator’s judgement.

You likely can't join if

  • Use of prohibited medications as specified in Section 6.8.2
  • History of ongoing, chronic or recurrent infectious disease (i.e., human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), active tuberculosis infection (TB))
  • 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 including but not limited to below: • Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the study. • Underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal, such as active inflammatory bowel disease), which in the opinion of the investigator significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.

The study team makes the final eligibility decision.

Where it's taking place

  • Chile
  • Turkey
  • Mexico
  • United Kingdom
  • Colombia
  • South Africa
  • Canada
  • Brazil
  • Argentina
  • Australia
  • Switzerland
  • United States
  • Lebanon
  • Japan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Chile; Turkey; Mexico; United Kingdom; Colombia; South Africa and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.