Phase 3 Polymyalgia Rheumatica Trial, Terminated

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been diagnosed with Polymyalgia Rheumatica (PMR) using recognised international diagnostic standards.
• You are currently taking prednisone (a steroid) at a dose of at least 7.5 mg per day but no more than 20 mg per day at the time of screening.
• You are willing and able to take prednisone at 15 mg per day at the point of joining the trial.
• You have already been treated with prednisone at a dose of 10 mg per day or more for at least 8 weeks in the past.
• You have had at least one clear flare-up of PMR symptoms — such as pain in the shoulders and/or hips along with stiffness caused by inflammation — while trying to reduce your prednisone dose (when the dose was still at least 7.5 mg per day), and this happened within the last 12 weeks.
• Within the past 12 weeks, blood tests showed signs of inflammation linked to your PMR (a specific blood marker called ESR was 30 or above, and/or another marker called CRP was 10 or above).

Who may not be able to join:

• You have been diagnosed with giant cell arteritis (a related condition that can cause headaches, jaw pain, vision problems, or stroke-like symptoms).
• You have been diagnosed with active fibromyalgia.
• You have rheumatoid arthritis, another type of inflammatory joint disease, or certain other immune system conditions such as lupus, scleroderma, vasculitis, myositis, or ankylosing spondylitis.
• You have a muscle-breakdown condition (rhabdomyolysis) or a nerve-related muscle disease.
• You have an underactive thyroid that is not being properly treated.
• You have had an organ transplant.
• You have previously tried a specific type of biological medication that targets a protein called interleukin-6 and it did not work, caused problems, or is not suitable for you.
• You have recently used or are currently using certain immune-suppressing medications (various specific drugs have different required waiting periods before you could join — confirm with trial site).
• Your dose of methotrexate has changed recently or is higher than 15 mg per week within the past 3 months.
• You are taking steroid tablets (like prednisone) for any condition other than PMR at the same time.
• You are pregnant or breastfeeding.
• You have active tuberculosis (TB) or an untreated latent (hidden/inactive) TB infection.
• You have a history of serious infections that are difficult for the body to fight (known as opportunistic infections).
• You currently have a fever caused by an infection, or you have a long-lasting or recurring infection that requires treatment.
• You have diabetes that is not well controlled.
• You have skin ulcers that have not healed or are still healing.
• You have received a live vaccine (such as certain flu, shingles, or travel vaccines) within the 3 months before joining.
• You have tested positive for hepatitis B, hepatitis C, or HIV.
• You have a history of shingles (herpes zoster) that has come back or been active.
• You have had a previous infection in a joint or a joint replacement.
• You have a current or past history of cancer (confirm with trial site).
• You have had surgery within 4 weeks of screening, or you are planning to have surgery during the study period.
• You have a history of inflammatory bowel disease, severe diverticulitis, or a previous tear or hole in the digestive tract (gastrointestinal perforation).

Important: Always verify eligibility with the trial site directly before applying.