Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis (UC)
A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects With Active Ulcerative Colitis
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Approximately 165 participants (55 subjects per arm) will be randomized in a 1:1:1 ratio to receive oral apremilast (30 mg BID or 40 mg BID), or identically appearing placebo BID for up to 12 weeks, followed by 40 weeks of blinded treatment with apremilast (30 mg BID or 40 mg BID).
At the end of the Blinded Active-treatment Phase (Week 52), participants who have a Mayo endoscopy score ≤ 1 will have the opportunity to participate in the Extension Phase. Participants enrolled in the Extension Phase will receive apremilast for an additional 52 weeks (Weeks 52 to 104). With the implementation of Amendment 4, participants entering the Extension Phase will receive apremilast 30 mg BID. Subjects currently in the Extension Phase who are receiving apremilast 40 mg BID will be switched to 30 mg BID at the next scheduled visit.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Accesso esteso
Contatti e Sedi
Luoghi di studio
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New South Wales
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Concord, New South Wales, Australia, 2139
- Concord Repatriation General Hospital
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Liverpool, New South Wales, Australia, 2170
- Liverpool Hospital
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Queensland
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South Brisbane, Queensland, Australia, 4101
- Mater Adult Hospital
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Victoria
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Footscray, Victoria, Australia, 3011
- Footscray Hospital
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Parkville, Victoria, Australia, 3050
- Royal Melbourne Hospital
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Plovdiv, Bulgaria, 4002
- Multiprofile Hospital for Active Treatment Kaspela
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Sofia, Bulgaria, 1303
- Medical Center Asklepion - Humane Medicine Research EOOD
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Sofia, Bulgaria, 1431
- University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
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Sofia, Bulgaria, 1407
- University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia
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Sofia, Bulgaria, 1527
- University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
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Sofia, Bulgaria, 1784
- Clinic of Gastroenterology
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Varna, Bulgaria, 9010
- Multiprofile Hospital for Active Treatment Sveta Marina EAD
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1R9
- Winnipeg Regional Health Authority - Health Sciences Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- Hamilton Health Sciences Corporation, McMaster University Medical Centre
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Brno, Cechia, 656 91
- Fakultni nemocnice u sv Anny v Brne
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Hradec Kralove, Cechia, 500 05
- Fakultni nemocnice Hradec Kralove
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Hradec Králové, Cechia, 500 12
- Hepato-Gastroenterologie HK, s. r. o.
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Slany, Cechia, 274 01
- Nemocnice Slany
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Kazan, Federazione Russa, 420064
- Republican Clinical Hospital
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Moscow, Federazione Russa, 115088
- Stolitsa-Medikl, LLC
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Rostov on Don, Federazione Russa, 344022
- SEIHPE Rostov State Medical University of MoH of RF
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Saratov, Federazione Russa, 410053
- Regional Clinical Hospital
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St Petersburg, Federazione Russa, 129329
- Russian Medical Military Academy na SMKirov
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Amiens, Francia, 80054
- Amiens University Hospital
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Clichy, Francia, 92110
- Hôpital Beaujon
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Nantes, Francia, 602 00
- CHRU Nantes
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Nice, Francia, 06202
- CHU de Nice Archet I
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Pierre Bénite, Francia, 69495
- Centre Hospitalier Lyon Sud
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Saint Priest en Jarez, Francia, 42055
- Centre Hospitalier Universitaire de Saint Etienne
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Vandoeuvre les Nancy, Francia, 54511
- Chru Nancy
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Berlin, Germania, 14050
- DRK Kliniken Berlin Westend
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Frankfurt, Germania, 60594
- Crohn-Colitis-Centre Rhein-Main
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Keil, Germania, 24105
- Universitätsklinikum Schleswig-Holstein
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Minden, Germania, 32423
- Gastroenterologische Praxis Minden
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Bologna, Italia, 40138
- Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi
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Milan, Italia, 20089
- IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center
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Palermo, Italia, 90146
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
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Roma, Italia, 00168
- Complesso Integrato Columbus
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Roma, Italia, 00133
- Fondazione PTV Policlinico Tor Vergata
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Auckland, Nuova Zelanda, 1023
- Auckland City Hospital
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Christchurch, Nuova Zelanda, 8011
- Christchurch Hospital
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Dunedin, Nuova Zelanda, 9016
- Dunedin Hospital
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Hamilton, Nuova Zelanda, 3204
- Waikato Hospital
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Groningen, Olanda, 9713 GZ
- Universitair Medisch Centrum Groningen
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Rotterdam, Olanda, 3083 AN
- Ikazia Ziekenhuis
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Bialystok, Polonia, 15-276
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Bydgoszcz, Polonia, 85-794
- Osrodek Badan Klinicznych CLINSANTE S.C.
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Czestochowa, Polonia, 42 202
- Centrum Medyczne Sw. Lukasza
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Katowice, Polonia, 40 659
- Economicus - NZOZ ALL-MEDICUS
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Sopot, Polonia, 81-756
- Endoskopia Sp. z o.o.
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Szczecin, Polonia, 71-685
- Sonomed Sp. z o.o.
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Torun, Polonia, 40 659
- Gastromed Kopon Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii Spec. Gabinety Lekarskie
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Warsaw, Polonia, 00-632
- Centrum Zdrowia Matki, Dziecka i Mlodziezy
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Warszawa, Polonia, 03-563
- Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
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Wroclaw, Polonia, 03-580
- Lexmedica Drubajlo Hanna
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Wroclaw, Polonia, 53-333
- ARS Médica
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Alabama
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Dothan, Alabama, Stati Uniti, 36305
- Digestive Health Specialists of the Southeast
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California
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Los Angeles, California, Stati Uniti, 90045
- Southern California Research Institute Medical Group, Inc.
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Connecticut
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Bristol, Connecticut, Stati Uniti, 06010
- Connecticut Clinical Research Foundation
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Florida
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Boynton Beach, Florida, Stati Uniti, 33426
- Consultants for Clinical Research of South Florida
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DeLand, Florida, Stati Uniti, 32720
- Avail Clinical Research, LLC
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Lauderdale Lakes, Florida, Stati Uniti, 33319
- Precision Clinical Research, LLC
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Miami, Florida, Stati Uniti, 33126
- Pharmax Research Clinic, Inc.
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Naples, Florida, Stati Uniti, 34102
- Gastroenterology Group Of Naples
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Port Orange, Florida, Stati Uniti, 32127
- Advanced Medical Research Center
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Illinois
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Chicago, Illinois, Stati Uniti, 60637
- University of Chicago Medical Center
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Iowa
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Iowa City, Iowa, Stati Uniti, 52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40202
- University of Louisville
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Massachusetts
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Worcester, Massachusetts, Stati Uniti, 01655
- UMASS Medical Center
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Michigan
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Chesterfield, Michigan, Stati Uniti, 48047
- Clinical Research Institute of Michigan, LLC
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Troy, Michigan, Stati Uniti, 48098
- Center for Digestive Health Research
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Mississippi
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Flowood, Mississippi, Stati Uniti, 39232
- Gastrointestinal Associates PA
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New York
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Great Neck, New York, Stati Uniti, 11021
- NYU Langone Long Island Clinical Research Associates
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45219
- Consultants for Clinical Research
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37211
- Quality Medical Research
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Texas
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Live Oak, Texas, Stati Uniti, 78233
- Digestive Research Center/ Gastroenterology Consultants of San Antonio
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Pasadena, Texas, Stati Uniti, 77505
- Digestive Health Specialist of Tyler
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San Antonio, Texas, Stati Uniti, 78229
- San Antonio Gastroenterology
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Utah
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Salt Lake City, Utah, Stati Uniti, 84132
- University of Utah
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Washington
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Seattle, Washington, Stati Uniti, 98195
- University of Washington Medical Center
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Seattle, Washington, Stati Uniti, 98104
- Harborview Medical Center
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Ivano-Frankivsk, Ucraina, 76018
- Ivano-Frankivsk Central City Clinical Hospital
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Ivano-Frankivsk, Ucraina, 58001
- Regional Clinical Hospital, Gastroenterology department, State Higher Education Institute Ivano-Frankivsk National Medical University
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Ivano-Frankivsk, Ucraina, 76008
- Ivano-Frankivsk Regional Clinical Hospital
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Kharkiv, Ucraina, 61037
- Kharkiv City Clinical Hospital 2
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Kirovograd, Ucraina, 25006
- Private Enterprise Private Manufacture Company Acinus
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Kremenchuk, Ucraina, 39617
- Kremenchuk City Hospital # 1 n.a O.T.Bohaievskyi
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Lviv, Ucraina, 79059
- Lviv Emergency Clinical Hospital, Therapeutics Department No. 1
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Odesa, Ucraina, 65025
- Municipal Institution Odesa Regional Clinical Hospital
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Uzhgorod, Ucraina, 88000
- Central City Clinical Hospital
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Vinnytsia, Ucraina, 21018
- Vinnytsia Regional Clinical Hospital n a M I Pyrohov
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Zaporizhzhia, Ucraina, 69600
- Municipal Institution Zaporizhzhia
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Budapest, Ungheria, 1139
- Endomedix Kft.
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Budapest, Ungheria, 1136
- Pannonia Maganorvosi Centrum Kft.
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Debrecen, Ungheria, 4025
- Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja
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Mosonmagyaróvár, Ungheria, 9200
- Karolina Korhaz Rendelointezet
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Szeged, Ungheria, 6720
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
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Szekszárd, Ungheria, 7100
- Tolna Megyei Balassa Janos Korhaz
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Vác, Ungheria, 2600
- Javorszky Odon Korhaz
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
- Male or female aged 18 and over at the time of signing the informed consent.
- Must understand and voluntarily sign an informed consent form prior to any study related assessments/procedures being conducted.
- Diagnosis of ulcerative colitis (UC) with a duration of at least 3 months prior to the Screening Visit..
- Total Mayo Score (TMS) ≥ 6 to ≤ 11 (range: 0-12) at baseline, prior to randomization in the study.
- Endoscopic subscore ≥ 2 (range: 0-3) on the Mayo score prior to randomization in the study.
- Subjects must have had a therapeutic failure, been intolerant to, or have a contraindication to, at least one of the following: oral aminosalicylates (ie, 5-aminosalicylic acid [5-ASA] compounds or sulfasalazine [SSZ]), budesonide, systemic corticosteroids, or immunosuppressants (eg, 6-mercaptopurine [6-MP], azathioprine [AZA], or methotrexate [MTX]).
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
- Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis.
- Ulcerative colitis restricted to the distal 15 cm or less (eg, ulcerative proctitis).
- Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study.
- Clinical signs suggestive of fulminant colitis or toxic megacolon.
- Prior use of any tumor necrosing factor (TNF) inhibitor (or any biologic agent).
- Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine or thalidomide.
- Use of intravenous (IV) corticosteroids within 2 weeks of the Screening Visit.
- Use of immunosuppressants (AZA, 6-MP or MTX) within 8 weeks of the Screening Visit.
- Use of topical treatment with 5-ASA or corticosteroid enemas or suppositories within 2 weeks of the Screening Visit.
- History of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the investigator's opinion, would preclude participation in the study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Apremilast 30 mg PO BID
Apremilast 30 mg by mouth (PO) twice a day (BID) for 12 weeks After 12 weeks:
After 52 weeks, participants who are eligible for the Extension Phase will continue to receive the same dose of apremilast assigned at Wk 12 (30 mg BID or 40 mg BID) for an additional 52 weeks (Wk 104) |
Altri nomi:
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Sperimentale: Apremilast 40 mg PO BID
Apremilast 40 mg by mouth (PO) twice a day (BID) for 12 weeks After 12 weeks, participants assigned to the 40 mg BID dose of apremilast at baseline will continue to receive apremilast 40 mg BID for an additional 40 weeks (Wk 52) After 52 weeks, participants who are eligible for the extension Phase will continue to receive apremilast 40 mg BID for an additional 52 weeks (Wk 104) |
Altri nomi:
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Comparatore placebo: Placebo BID
Identically matching placebo by mouth (PO) twice a day (BID) for 12 weeks. After 12 weeks all participants randomized to placebo at baseline will be re-randomized to receive apremilast 30 mg or 40 mg BID for an additional 40 weeks (Wk 52) After Wk 52, participants who are eligible for the extension phase will continue to receive the same dose of apremilast assigned at Wk 12 (30 mg BID or 40 mg BID) for an additional 52 weeks (Wk 104) |
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score (TMS) at Week 12
Lasso di tempo: Week 12
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Clinical remission was defined as a total Mayo score ≤ 2 points, with no individual subscore exceeding 1 point. The TMS is an instrument designed to measure disease activity of UC. The Mayo score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease.
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Week 12
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score and the Reduction in the Rectal Bleeding Subscore at Week 12
Lasso di tempo: Week 12
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Clinical response was defined as a decrease from baseline in the TMS of at least 3 points and at least 30%, along with a reduction in the rectal bleeding subscore (RBS) of at least 1 point or an absolute RBS of ≤ 1. The TMS is an instrument designed to measure disease activity of UC. The Mayo score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease.
Rectal bleeding (subscore 0-3) was defined as: 0 = No blood seen
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Week 12
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Percentage of Participants Who Achieved an Endoscopic Remission at Week 12
Lasso di tempo: Week 12
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An endoscopic remission was defined as a Mayo endoscopic subscore (MES) of 0 at Week 12. The MES subscore findings were defined as: 0 = Normal or inactive disease
The endoscopy subscores consisted of findings that were centrally read through proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease. Two-sided 95% CIs for the within-group percentage were based on the Wilson score method. |
Week 12
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Percentage of Participants Who Achieved an Endoscopic Response at Week 12
Lasso di tempo: Week 12
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An endoscopic response is defined as a decrease from baseline of at least 1 point in the MES at Week 12. The Mayo endoscopy subscore findings were defined as: 0 = Normal or inactive disease
The endoscopy subscores consisted of findings that were centrally read through proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease. Two-sided 95% CIs for the within-group percentage were based on the Wilson score method. |
Week 12
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Percentage of Participants Who Achieved a Rectal Bleeding Subscore (RBS) of ≤ 1 at Week 12
Lasso di tempo: Week 12
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The RBS was measured as: 0 = No blood seen
The daily bleeding score represents the most severe bleeding of the day. Two-sided 95% CI for the within-group proportions are based on the Wilson score method. |
Week 12
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Percentage of Participants Who Achieved Clinical Remission in the Modified Mayo Subscore (MMS) at Week 12
Lasso di tempo: Week 12
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Clinical remission was defined as a modified Mayo score of ≤ 2, with no individual subscore > 1, at Week 12.
The MMS was based on a modification of the total Mayo score (TMS) which included the stool frequency, rectal bleeding, and endoscopic subscores of the TMS and excluded the Physician's Global Assessment (PGA) subscore, since this was a global measure that is subjective in nature.
The MMS ranges from 0 to 9 points with higher scores indicating greater disease severity.
The endoscopy subscores was centrally reviewed.
Two-sided confidence intervals for the within-group percentage were based on the Wilson score method.
|
Week 12
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Percentage of Participants Who Achieved Clinical Response in the Modified Mayo Subscore (MMS) at Week 12
Lasso di tempo: Week 12
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Clinical response in the MMS was defined as a decrease from baseline in the MMS of at least 2 points and at least 25%, along with a reduction in the RBS of at least 1 point or an absolute RBS ≤ 1. The MMS was based on the stool frequency, rectal bleeding, and endoscopic subscores of the TMS and excluded the PGA subscore. The MMS ranges from 0 to 9 points with higher scores indicating greater disease severity. The RBS was measured as: 0 = No blood seen
The daily bleeding score represents the most severe bleeding of the day. The endoscopy subscores was centrally reviewed. Two-sided confidence intervals for the within-group percentage were based on the Wilson score method. |
Week 12
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Percentage of Participants Who Achieved Clinical Remission in the Partial Mayo Subscore (PMS) With no Individual Subscore >1 at Week 8
Lasso di tempo: Week 8
|
Clinical remission in the partial Mayo subscore was defined as a PMS of 2 points or lower, with no individual subscore >1. The PMS is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores: Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). Two-sided 95% CI for the within-group proportions are based on the Wilson score method. |
Week 8
|
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Percentage of Participants Who Achieved Clinical Response in the Partial Mayo Subscore at Week 8
Lasso di tempo: Week 8
|
Clinical response in the PMS was defined as a decrease from baseline in PMS of at least 2 points and at least 25%, with an accompanying decrease in the RBS of at least 1 point or an absolute RBS of 0 or 1. The PMS score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores: Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). Two-sided 95% CI for the within-group proportions are based on the Wilson score method. |
Week 8
|
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The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase
Lasso di tempo: From the first dose of investigational product (IP) and no later than 28 days after the last dose of IP for those who had completed the study or discontinued (D/C) early; maximum duration of exposure to treatment was 12.00 weeks
|
A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of apremilast and up to 28 days after the last apremilast dose or the last follow-up date, whichever occurred earlier.
A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.
The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain
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From the first dose of investigational product (IP) and no later than 28 days after the last dose of IP for those who had completed the study or discontinued (D/C) early; maximum duration of exposure to treatment was 12.00 weeks
|
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The Number of Participants Who Discontinued Apremilast Due to Treatment Emergent Adverse Events During the Placebo-Controlled Period
Lasso di tempo: From the first dose of IP and no later than 28 days after the last dose of IP for those who had completed the study or discontinued early; median duration of exposure to treatment was 12.00 weeks
|
A TEAE was defined as any AE occurring or worsening on or after the first treatment of apremilast and up to 28 days after the last apremilast dose or the last follow-up date, whichever occurred earlier.
A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.
The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.
|
From the first dose of IP and no later than 28 days after the last dose of IP for those who had completed the study or discontinued early; median duration of exposure to treatment was 12.00 weeks
|
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The Number of Participants Who Experienced TEAEs During the Apremilast (APR) Exposure Period (Active Treatment Phase) Through Week 52
Lasso di tempo: From first dose of IP and no later than 28 days after last dose of IP for those who completed the active treatment phase or D/C early; median duration of exposure = 41.00, 44.15 and 40.00 weeks respectively for 30 mg, 40 mg and 30 mg/40 mg APR arms
|
A TEAE was defined as any AE occurring or worsening on or after the first treatment of apremilast and up to 28 days after the last apremilast dose or the last follow-up date, whichever occurred earlier.
A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.
The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain
|
From first dose of IP and no later than 28 days after last dose of IP for those who completed the active treatment phase or D/C early; median duration of exposure = 41.00, 44.15 and 40.00 weeks respectively for 30 mg, 40 mg and 30 mg/40 mg APR arms
|
|
The Number of Participants Who Experienced TEAEs During Week 52 to Week 104 (Extension Phase)
Lasso di tempo: From the first dose of IP at Week 52 and no later than 28 days after the last dose of IP for those who completed the study or had discontinued early; median exposure of apremilast for the total apremilast group was 52 weeks.
|
A TEAE was defined as any AE occurring or worsening on or after the first treatment of apremilast and up to 28 days after the last apremilast dose or the last follow-up date, whichever occurred earlier.
A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.
The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain
|
From the first dose of IP at Week 52 and no later than 28 days after the last dose of IP for those who completed the study or had discontinued early; median exposure of apremilast for the total apremilast group was 52 weeks.
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Processi patologici
- Malattie gastrointestinali
- Gastroenterite
- Malattie del colon
- Malattie intestinali
- Malattie infiammatorie intestinali
- Ulcera
- Colite
- Colite, ulcerosa
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti del sistema nervoso periferico
- Inibitori enzimatici
- Analgesici
- Agenti del sistema sensoriale
- Agenti antinfiammatori, non steroidei
- Analgesici, non narcotici
- Agenti antinfiammatori
- Agenti antireumatici
- Inibitori della fosfodiesterasi
- Inibitori della fosfodiesterasi 4
- Apremilast
Altri numeri di identificazione dello studio
- CC-10004-UC-001
- 2014-002981-64 (Numero EudraCT)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- Protocollo di studio
- Piano di analisi statistica (SAP)
- Modulo di consenso informato (ICF)
- Relazione sullo studio clinico (CSR)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .