Polymayalgia Rheumatic - Upland CA

Summary:

Sanofi "A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patinets with polymyalgia rheumatic"

This study will last up to 62 weeks and made up of 3 periods:

- Screening Period: will last up to 4 weeks.

- Study Treatment period: will last 52 weeks.

- Follow-up period: Will last 6 weeksfrom the end of the study trematment period.

Diagnosis of PMP accrding to the European Leauge against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria as follows ( must satisfy all criteria ) :

a) Age ≥50 years at time of diagnosis

b) Bilateral shoulder pain

c) Elevated acute phase reactants ( CRP >10 mg/L and/or ESR >30 mm/hr).

Qualified Participants May Receive:

1. Sarilumab or its matching placebo (dummy medicine made to look like sarilumab) will be provided to you in single-use prefilled glass syringes for subcutaneous injection in the abdomen, thigh, or upper arm every two weeks for a total of 26 injectons lasting 52 weeks.

2. Prednisone or its matching placebo (dummy medicines made to look like prednisone) over-encapsulated tablest will be taken orally every day for 52 weeks. Prednisone or ints matching placebo will be provided to you in a kit with four weekly wallets that will clearly indicate which over-encapsulated tablets to be taken every day, the order in which the wallets need to be used and the order in which the kits need to be taken if more than one kit it is given to you at on time.

3. Qualified participants will be paid $50.00 for each completed study visit.  If you withdraw from the study before completion, you will be paid for each study visit you completed.  You will be paid at the end of each study visit or at the end of your participation in the study, whichever you perfer.