- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01958827
A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease
A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics After Dose Escalation in Japanese Subjects With Crohn's Disease
Přehled studie
Detailní popis
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Subject ≥ 15 years of age at the time of informed consent.
- Subject with Crohn's disease who received induction treatment of commercially available Humira® (160 mg initially and 80 mg at 2 weeks after initial dose), achieved response after initial dose, and then lost response during maintenance treatment with Humira®.
- Subject with elevated C-reactive Protein (CRP) at Screening.
- If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after the last dose of study drug.
- Subject has a negative tuberculosis (TB) screening assessment. If the subject has evidence of a latent TB infection; the subject must initiate and complete a minimum of 21 days of an ongoing TB prophylaxis (in such case, screening period can be prolonged until 21 days past after initiation of prophylaxis and study drug is administered) or have documented completion of a full course of TB prophylaxis, prior to Week 0.
Exclusion Criteria:
- Subject with suspicion of colitis other than Crohn's disease.
- Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).
- Subject with abscess or suspicion of abscess, or subject with infection(s).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Adalimumab 80 mg
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
Adalimumab v předplněné injekční stříkačce podávaný subkutánní injekcí.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8
Časové okno: Week 8
|
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease.
A score below 150 indicates remission and a score above 450 indicates severe disease.
Non-responder imputation (NRI) for missing CDAI observations was used.
|
Week 8
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Časové okno: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease.
A score below 150 indicates remission and a score above 450 indicates severe disease.
Non-responder imputation (NRI) for missing CDAI observations was used.
|
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52
Časové okno: Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease.
A score below 150 indicates remission and a score above 450 indicates severe disease.
Non-responder imputation (NRI) for missing CDAI observations was used.
Week 8 was the primary outcome measure.
|
Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
Časové okno: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease.
A score below 150 indicates remission and a score above 450 indicates severe disease.
Non-responder imputation (NRI) for missing CDAI observations was used.
|
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
Časové okno: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease.
A score below 150 indicates remission and a score above 450 indicates severe disease.
Non-responder imputation (NRI) for missing CDAI observations was used.
|
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
Časové okno: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
C-reactive protein (CRP) was measured from blood samples as a marker for inflammation.
Higher levels are indicative of more inflammation.
Normal concentration in healthy human serum is usually lower than 0.3 mg/dL, slightly increasing with age.
Last Observation Carried Forward (LOCF) was used for missing data.
|
Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
Number of Participants With Potentially Significant Hematology Parameters
Časové okno: 52 weeks
|
Blood was collected for analysis at designated study visits; hematology results were provided by each site laboratory.
The number of participants with an abnormal laboratory result (higher than upper limit of normal [ULN] or lower than lower limit of normal [LLN]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized.
Increase is signified by ↑. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value.
|
52 weeks
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Časové okno: 52 weeks
|
Blood was collected for analysis at designated study visits; chemistry results were provided by a central laboratory.
The number of participants with an abnormal laboratory result (higher than upper limit of normal [ULN] or lower than lower limit of normal [LLN]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized.
n=the number of participants with CTC Grade <3 at baseline and a post-baseline value for each parameter.
|
52 weeks
|
Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Časové okno: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
Blood pressure was measured while the participant was sitting.
n=the number of participants with available data at each time point.
|
Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Časové okno: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
Blood pressure was measured while the participant was sitting.
n=the number of participants with available data at each time point.
|
Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Časové okno: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
Heart rate was measured while the participant was sitting.
n=the number of participants with available data at each time point.
|
Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
Časové okno: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
n=the number of participants with available data at each time point.
|
Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
Number of Participants With Adverse Events (AEs)
Časové okno: 60 weeks
|
An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug. For more details on adverse events please see the AE section below. |
60 weeks
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52
Časové okno: Baseline (Week 0) to Week 52
|
Blood samples were drawn prior to drug administration.
Adalimumab concentrations in serum were determined using a validated heterogeneous electrochemiluminescence (ECL)-immunoassay method.
The assay captures adalimumab via biotinylated anti-idiotypic antibody, and detects it via sulfo-tagged TNF-alpha.
n=the number of participants with available data at each time point.
|
Baseline (Week 0) to Week 52
|
Change in Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 52
Časové okno: Baseline (Week 0) to Week 52
|
Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses.
Samples were considered AAA positive if the measured AAA concentration was above 20 ng/mL.
A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose.
|
Baseline (Week 0) to Week 52
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Morio Ozawa, MS, AbbVie GK.
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- M13-687
- 2015-004121-13 (Číslo EudraCT)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Crohnova nemoc
-
National Institute of Allergy and Infectious Diseases...UkončenoChronické granulomatózní onemocnění | Zánětlivé onemocnění střev (IBD) | IBD typu Crohn'SSpojené státy
Klinické studie na Adalimumab
-
PfizerDokončenoZdravýSpojené státy, Belgie
-
PfizerDokončenoZdravé předmětySpojené státy
-
Shanghai Henlius BiotechDokončeno
-
AbbottStaženo
-
AbbottDokončenoArtritida, juvenilní idiopatickáSpojené státy, Belgie, Česká republika, Francie, Německo, Itálie, Slovensko, Španělsko
-
AbbottDokončeno
-
Mylan Inc.Mylan GmbHDokončenoPsoriáza | Artritida, psoriatikaBulharsko, Estonsko, Maďarsko, Polsko, Ruská Federace, Ukrajina
-
AbbottDokončenoRevmatoidní artritidaŠpanělsko
-
Turgut İlaçları A.Ş.Dokončeno
-
SandozHexal AGDokončenoPsoriáza plakového typuSpojené státy, Francie, Bulharsko, Slovensko