Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)

PHASE3CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

June 30, 2008

Study Completion Date

August 31, 2008

Conditions
Familial Cold Autoinflammatory Syndrome (FCAS)Familial Cold UrticariaMuckle-Wells Syndrome (MWS)Genetic Diseases, Inborn
Interventions
DRUG

rilonacept 160 mg

Rilonacept was given by subcutaneous injection. It was administered weekly at the dose of 160mg. On Day 1, subjects received two injections of rilonacept (for a total of 320 mg).

DRUG

Placebo

Subcutaneous injection of Placebo occurred during first 6 weeks of the study or during randomized withdrawal (weeks 15-24). On Day 1, subjects received two placebo injections.

DRUG

rilonacept 160 mg

Rilonacept was given by subcutaneous injection. It was administered weekly at the dose of 160mg. No loading dose was given for subjects who entered directly into the open-label.

Trial Locations (24)

10023

New York

16635

Duncansville

24551

Forest

27609

Raleigh

29201

Columbia

29651

Greer

30342

Atlanta

31904

Columbus

32216

Jacksonville

34996

Stuart

37403

Chattanooga

40215

Louisville

45236

Cincinnati

48047

Chesterfield

60504

Aurora

63141

St Louis

71105

Shreveport

72204

Little Rock

75235

Dallas

76712

Waco

84720

Cedar City

91786

Upland

92260

Palm Desert

98499

Lakewood

All Listed Sponsors
lead

Regeneron Pharmaceuticals

INDUSTRY

NCT00288704 - Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) | Biotech Hunter | Biotech Hunter