Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness for Patients With Systemic Sclerosis With Interstitial Lung Disease

PHASE2TerminatedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

August 9, 2012

Primary Completion Date

November 3, 2016

Study Completion Date

November 3, 2016

Conditions
Scleroderma, SystemicSclerosis, SystemicSystemic SclerodermaSystemic SclerosisInterstitial Lung Disease
Interventions
DRUG

Pomalidomide (CC-4047)

1 mg orally every day for 52 weeks

DRUG

Placebo

Matching placebo capsules taken orally once a day

Trial Locations (56)

3168

Monash Medical Centre, Clayton

4031

University Hospital Basel, Basel

4032

The Prince Charles Hospital, Chermside

5011

The Queen Elizabeth Hospital, Woodville South

10117

Charite - Universitätsmedizin Berlin, Berlin

11021

North Shore-LIJ Health System-Division of Rheumatology, Great Neck

15261

University of Pittsburgh, Pittsburgh

15706

Complejo Hospitalario de Santiago, Santiago de Compostela

16132

Azienda Ospedaliera Universitaria S. Martino di Genova, Genova

19104

University of Pennsylvania, Philadelphia

19713

Delaware Medical Care Associates, LLC, Newark

20057

Georgetown University School of Medicine, Washington D.C.

20122

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan

20157

Ospedale Luigi Sacco, Milan

27100

IRCCS Policlinico S. Matteo di Pavia, Pavia

28007

Hospital Universitario Gregorio Maranon, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

30281

Arthritis Research and Treatment Center, Stockbridge

33612

USF Health Faculty Office Building-FOB, Tampa

43614

University of Toledo College of Medicine, Toledo

44195

Cleveland Clinic, Cleveland

44652

Rheumazentrum Ruhrgebiet, Herne

46017

Hospital Universitario Dr. Peset, Valencia

46360

LaPorte County Institute for Clinical Research, Inc, Michigan City

48109

University of Michigan, Ann Arbor

53226

Medical College of Wisconsin, Milwaukee

56126

Azienda Ospedaliera Universitaria Pisana, Pisa

59037

CHRU de Lille FR, Lille

60590

Klinikum der J.W. Gothe-Universitat Frankfurt, Frankfurt

60612

University of Illinois at Chicago, Chicago

61231

Kerckhoff-Klinik gGmbH, Bad Nauheim

71103

Louisiana State University, Shreveport

75010

Hopital Saint Louis, Paris

75014

Groupe Hospitalier Saint Vincent de Paul, Paris

77030

University of Texas Health Science Center at Houston, Houston

89081

University Hospital of Ulm, Ulm

90095

UCLA Division of Rheumatology, Los Angeles

91054

University of Erlangen-Nuremberg, Erlangen

92270

Advances in Medicine, Rancho Mirage

115522

Institution of the Russian Academy of Medical Sciences Research Institute of Rheumatology of the Ru, Moscow

190068

"St. Petersburg State Healthcare Institution Clinical Rheumatology Hospital # 25", Saint Petersburg

440026

Penza Regional Clinical Hospital n.a. N.N. Burdenko, Penza

40536-0284

University of Kentucky, Lexington

02118

Boston University of Medicine BUMC, Boston

08903

UMDNJ-Robert Wood Johnson Medical School Clinical Research Center, New Brunswick

00161

Policlinico Umberto I, Roma

00168

Policlinico Universitario Agostino Gemelli, Roma

15-297

Centrum Miriada Prywatny Gabinet Specjalistyczny Profesora Dra Stanislawa Sierakowskiego, Bialystok

85-168

Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy, Bydgoszcz

40-634

SPSK Nr 7 Slaskiego Uniwersytetu Medycznego, Oddzial Chorob Wewnetrznych i Reumatologii, Katowice

71-252

Samodzielny Publiczny Szpital Kliniczny nr 1 im. prof.Tadeusza Sokolowskiego Pomorskiego UM w Szczec, Szczecin

02-637

Instytut Reumatologii, Klinika i Poliklinika Ukladowych Chorób Tkanki Lacznej, Warsaw

50-556

Akademicki Szpital Kliniczny Klinika Reumatologii i Chorob Wewnetrznych, Wroclaw

LS7 4SA

Chapel Allerton Hospital, Leeds

NW3 2PF

Royal Free Hospital, London

SW3 6NP

Royal Brompton Hospital - Interstitial Lung Disease Unit, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY