NCT02370550

Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome

Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this large multicenter, randomized, double-blinded, controlled clinical study is to investigate the efficacy and safety of Cyclosporin A for primary Sjogren's syndrome associated pneumonitis(pSS-IP), which has important implications for the establishment of standardized diagnosis and treatment of pSS-IP.

Conditions

• Sjogren's Syndrome

Interventions

Type	Name	Description
DRUG	Cyclosporin A	CsA 2-3 mg/kg/d, BID PO
DRUG	Prednisone	Prednisone 0.5mg/kg/d QD PO starting at Week 0. After 2-4 weeks, the initial dose is gradually tapered by 2.5 mg each week until a maintenance dosage of 5-7.5 mg/d through week 52 (visit 6). The initial and maintenance doses are determined by the investigators of each center depending on the patients.
DRUG	Placebo	Placebo tablet 2-3 mg/kg/d, BID PO
DRUG	Calcium carbonate D	Calcium carbonate D 600 mg, QD PO

Timeline

• Start date: 2015-03-01
• Primary completion: 2021-03-01
• Completion: 2021-12-01
• First posted: 2015-02-25
• Last updated: 2020-05-22

Locations

1 site across 1 country: China