Open-Label Study of Oral Treprostinil in Digital Ulcers (DISTOL-EXT)
8 janvier 2014 mis à jour par: United Therapeutics
Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: An Open-label Multicenter Extension Study
This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects with SSc and digital ulcers.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
115
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Ontario
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London, Ontario, Canada, N6A 4V2
- St Joseph's Health Care
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
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London, Royaume-Uni, NW3 2QG
- Royal Free Hospital - Center for Rheumatology
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Manchester, Royaume-Uni, M13 9PT
- Salford Royal Hospital
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Alabama
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Birmingham, Alabama, États-Unis, 35294-7201
- University of Alabama - Birmingham - Arthritis Clinical Intervention Program
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Arizona
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Scottsdale, Arizona, États-Unis, 85259
- Mayo Clinic Scottsdale
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California
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Los Angeles, California, États-Unis, 90095-1670
- UCLA
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Colorado
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Aurora, Colorado, États-Unis, 80045
- Barbara Davis Centre
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Connecticut
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Farmington, Connecticut, États-Unis, 06030-1310
- University of Connecticut Health Center
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District of Columbia
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Washington, District of Columbia, États-Unis, 20007
- Georgetown University - Dept. of Medicine/Rheumatology
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Northwestern University - Feinberg School of Medicine
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Maryland
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Baltimore, Maryland, États-Unis, 21224
- Johns Hopkins University - Division of Rheumatology
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Massachusetts
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Boston, Massachusetts, États-Unis, 02118-2526
- Boston University School of Medicine
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Michigan
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Ann Arbor, Michigan, États-Unis, 48106
- University of Michigan - Scleroderma Program
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota
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New Jersey
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New Brunswick, New Jersey, États-Unis, 08903
- UMDNJ Clinical Research Center
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New York
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Lake Success, New York, États-Unis, 11042
- North Shore - LIJ Health System
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New York, New York, États-Unis, 10021
- The Hospital for Special Surgery
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Ohio
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Cleveland, Ohio, États-Unis, 44195
- The Cleveland Clinic Foundation
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Toledo, Ohio, États-Unis, 43614
- University of Toledo
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15261
- University of Pittsburgh
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South Carolina
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Charleston, South Carolina, États-Unis, 29425-8900
- Medical University of South Carolina
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Texas
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Houston, Texas, États-Unis, 77030
- University of Texas - Houston
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Utah
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Salt Lake City, Utah, États-Unis, 84132
- University of Utah
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Washington
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Seattle, Washington, États-Unis, 98101
- Virginia Mason Medical
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53226
- Medical College of Wisconsin
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Eligible subjects who completed assessments for the final visit of the previous TDE-DU-201 controlled trial and who signed appropriate informed consent were eligible to enroll in this extension study.
- If a female of childbearing potential, the subject must have agreed to continue practicing an acceptable method of birth control (i.e., surgical sterilization, approved hormonal contraceptives, barrier methods [such as a condom or diaphragm] used with a spermicide, or an intrauterine device).
Exclusion Criteria:
- Have had any change in clinical status that, in the opinion of the Investigator, would pose a safety risk for participation in this extension study;
- Have been found to be unable to complete study assessments in the previous controlled trial;
- Have prematurely discontinued study drug during the previous study due to clinical worsening or treatment related adverse events.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Treprostinil
Treprostinil diethanolamine sustained release tablet initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
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sustained release tablet; BID dosing; up to 16 mg BID
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Net Ulcer Burden- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment
Délai: Baseline and Months 1, 3, 6, 9, 12, and 18
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Net ulcer burden at any given assessment was defined as the number of "new" or "active" ulcers at that assessment, plus the number of "indeterminate" ulcers at that assessment that had previously been classified as either "active" or "new" at any earlier assessment during the study.
The mean change in net ulcer burden from time of study entry was summarized for each scheduled visit assessment.
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Baseline and Months 1, 3, 6, 9, 12, and 18
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Total Ulcer Number- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment
Délai: Baseline and Months 1, 3, 6, 9, 12, and 18
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The total ulcer number includes all ulcers designated as "active", "indeterminate", or "new" for a given visit.
The mean change in the total number of ulcers present from time of study entry was summarized for each scheduled visit assessment.
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Baseline and Months 1, 3, 6, 9, 12, and 18
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Formation of New Ulcers
Délai: 18 months (or last study visit)
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The number and percentage of subjects who developed new ulcers during the study were summarized.
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18 months (or last study visit)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Patient Function and QOL Measure: Scleroderma Health Assessments Questionnaire (SHAQ)- Mean Change From Study Entry in SHAQ Component Scores at Each Scheduled Assessment
Délai: Baseline and Months 1, 3, 6, and 12
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The SHAQ consists of 20 health assessment questionnaire questions with integer responses of 0 (without any difficulty) to 3 (unable to do), and five scleroderma-specific visual analog scale (VAS) domains (Overall Disease Activity, Raynaud's Phenomenon, Finger Ulcers, Breathing, and Intestinal Problems) with values ranging from 0.0 to 15.0 centimeters.
The questions are divided into eight component domains: Dressing & Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
Each domain score is calculated by summing the domain responses and dividing by the number of questions in that domain.
Each VAS domain score is calculated by dividing the value in centimeters by 5. SHAQ component and VAS domain score ranges from 0 (least limitation) to 3 (most limitation).
The aggregate SHAQ score is calculated by dividing the sum of all domain scores by 13, with a score ranging from 0 (least limitation) to 3 (most limitation).
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Baseline and Months 1, 3, 6, and 12
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Patient Function and Quality of Life Measure: Cochin Hand Function Scale (CHFS)-Mean Change From Study Entry in CHFS Score at Each Scheduled Assessment
Délai: Baseline and Months 1, 3, 6, and 12
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The CHFS score is derived from 18 validated questions that assess functional disability and handicap due to hand involvement in rheumatoid arthritis.
Each answer is scored on a scale with possible integer responses of 0(without difficulty) to 5 (impossible).
The CHFS score is simply the sum of all 18 questions, divided by the number of questions actually answered, multiplied by 18.
At least 10 of the 18 questions must have been answered in order for CHFS to be calculated.
Therefore, CHFS score values can range from 0 (least limitation) to 90 (most limitation), with improvements in function or reduction of limitation indicated a decreased score value.
The mean change from study entry in CHFS scores at each scheduled assessment are summarized.
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Baseline and Months 1, 3, 6, and 12
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: James Seibold, MD, Scleroderma Research Consultants LLC
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2009
Achèvement primaire (Réel)
1 septembre 2011
Achèvement de l'étude (Réel)
1 septembre 2011
Dates d'inscription aux études
Première soumission
16 février 2009
Première soumission répondant aux critères de contrôle qualité
19 février 2009
Première publication (Estimation)
20 février 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
7 février 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 janvier 2014
Dernière vérification
1 janvier 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TDE-DU-202
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Sclérodermie systémique
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University of Alabama at BirminghamRésiliéLymphome anaplasique à grandes cellules | Lymphome T angio-immunoblastique | Lymphomes T périphériques | Leucémie à cellules T de l'adulte | Lymphome T adulte | Lymphome T périphérique Non précisé | T/Null Cell Systemic Type | Lymphome cutané à cellules T avec maladie nodale/viscéraleÉtats-Unis
Essais cliniques sur treprostinil diethanolamine
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AOP Orphan Pharmaceuticals AGGCP-Service International Ltd. & Co. KG; ANOVA CRO s.r.o.; PharmaLex Belgium; Aixial...RecrutementHypertension artérielle pulmonaireL'Autriche, Espagne, France, Allemagne, Italie, Tchéquie, Hongrie, Pologne, Le Portugal, Roumanie