Clinical Trial 41114

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Upland, CA 91786


Study 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.

 


Study is Available At:

Inland Rheumatology Clinical Trials
1238. E. Arrow Hwy
Upland, CA 91786
View Clinic Location

 


If you or someone you care for is interested in participating in this clinical trial and lives within 75 miles of the clinic, please complete the form below and click 'I Am Interested In This Study'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.