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A trial of prednisolone in combination with SPI-62 or placebo in participants with polymyalgia rheumatica (PMR)
EU CTIS ID: 2024-517406-29-00
What this study is testing
To identify whether a prednisolone dose adjustment is necessary to provide equivalent efficacy when administered with SPI-62 in subjects with PMR and, if so, estimate the adjustment.
- Therapeutic exploratory (Phase II)
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
- 1. Written informed consent.
- 2. Diagnosis of PMR according to EULAR/ACR classification criteria
- 3. Absence of PMR relapse based on symptoms and acute phase markers.
- 4. Daily oral prednisolone 10 mg dose that will have been stable for at least 1 week at the Baseline Visit and is expected to remain stable during the treatment period.
You likely can't join if
- 1. Any contraindication for prednisolone administration.
- 2. A diagnosis or any clinical features of giant cell arteritis.
- 3. Any autoimmune disease (e.g., late-onset rheumatoid arthritis) other than PMR.
- 4. Use of medications for treatment of PMR within specified intervals prior to the Baseline Visit other than oral prednisolone.
- 5. Use of other medications likely to interfere with trial assessments.
- 6. History or diagnosis of endogenous hypercortisolism.
See the full eligibility criteria
- 1. Written informed consent.
- 2. Diagnosis of PMR according to EULAR/ACR classification criteria
- 3. Absence of PMR relapse based on symptoms and acute phase markers.
- 4. Daily oral prednisolone 10 mg dose that will have been stable for at least 1 week at the Baseline Visit and is expected to remain stable during the treatment period.
- 1. Any contraindication for prednisolone administration.
- 2. A diagnosis or any clinical features of giant cell arteritis.
- 3. Any autoimmune disease (e.g., late-onset rheumatoid arthritis) other than PMR.
- 4. Use of medications for treatment of PMR within specified intervals prior to the Baseline Visit other than oral prednisolone.
- 5. Use of other medications likely to interfere with trial assessments.
- 6. History or diagnosis of endogenous hypercortisolism.
- 7. Any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the trial or the evaluation of its results.
The study team makes the final eligibility decision.
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.
Explore other conditions
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.