Clinical TrialID 6649

Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis

NCT00221000

Rheumatoid Arthritis

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Record Fields

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Clinical Trial Id
6649
Evidence Id
6649
Core Evidence Id
6649
Source Clinical Trial Id
6635
Herb2 Clinical Trial Id
HBCT006635
Nct Id
NCT00221000
Title
Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Study Result
No
Study Condition
Rheumatoid Arthritis
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DRUG: Methoxsalen|PROCEDURE: Extracorporeal Photopheresis
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Quadruple
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
86
Outcome Measure
ACR 20, At least a 20% improvement of ACR 20 from baseline, week 24 and week 28
Sponsor Collaborator
Mallinckrodt
Funded By
INDUSTRY
Location
Carroll County Arthritis and Osteoporosis Center, Westminister, Maryland, United States|Clinical Pharmacology Study Group, Worchester, Massachusetts, United States|Morristown Memorial Hospital, Morristown, New Jersey, United States|AAIR Research Center, Rochester, New York, United States|Carolina Arthritis Associates, Wilmington, North Carolina, United States|Rheumatic Disease Associates, Willow Grove, Pennsylvania, United States|Rheumatology Associates, Providence, Rhode Island, United States|UT Southwestern Medical Center, Dallas, Texas, United States|Arthritis and Osteoporosis Center of South Texas, San Antonio, Texas, United States|Benaroya Research Institute at Virginia Mason, Seattle, Washington, United States|Royal Brisbane Hospital, Herston, Australia|General Hospital of Vienna, Vienna, Austria|Hospital Brugmann, Bruxelles, Belgium|Limburgs Universitair Centrum, Diepenbeek, Belgium|Rebecca MacDonald Centre for Arthritis, Toronto, Ontario, Canada|CHRU de Lille, Lille, France|Hopital Edouard Herriot, Lyon, France|Franz von Prummer Klinik, Bad Bruckenau, Germany|University of Charite Clinic for Rheumatology and Immunology, Berlin, Germany|Medizinische Klinik III, Erlangen, Germany|Abt. Rheumatologie und Klinische Immunologie, Hamburg, Germany|Klinikum der Universitat zu Koln, Koln, Germany|Westfalische wilhelms-universitat Munster, Munster, Germany|Medizinische Klinik des Evangelischen Kranken, Oldenburg, Germany|Universita degli Studi di Firenze, Firenze, Italy|Universita de Genova - Ospedale S. Martino, Genova, Italy|University of Siena-Italy, Siena, Italy|OPD- Hospital Civil "Dr. Jaun I. Menchaca", Guadalajara, Jalisco, Mexico|Reumatologicka ambulancia, Polinika, Bratislava, Slovakia|South African National Blood Service, Bloemfontein, South Africa|Christian Barnard Mermorial Hospital, Cape Town, South Africa|D6 Rheumatology Clinic and E5 Hematology Unit, Cape Town, South Africa
Other Id
RA-1
Start Date
2003-08
Primary Completion Date
2006-10
Completion Date
2006-11
First Posted
2005-09-22
Results First Posted
Last Update Posted
2016-10-19
Study Document
Study Url
https://clinicaltrials.gov/study/NCT00221000
Title Cn
Title En
Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis
Bilingual Status
semi_complete