A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease
11 marca 2016 zaktualizowane przez: AbbVie
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
The purpose of this study is to investigate the efficacy, safety and pharmacokinetics after dose escalation in Japanese subjects with Crohn's Disease.
Przegląd badań
Szczegółowy opis
Subjects who are confirmed to meet all of the inclusion criteria and none of the exclusion criteria during screening period (≤ 21 days) will be given subcutaneous injections of open-label adalimumab 80 mg eow from Week 0 to Week 50.
If a subject has an inadequate response at or after Week 8, the subject may be withdrawn from the study.
Self-injection of study drug is permitted for the subjects who are willing to perform self-injection, if the investigator decided as appropriate.
Disease activity will be evaluated by Crohn's disease activity index (CDAI) at Screening, Week 0 and every 4 weeks until Week 52.
Follow-up will be performed at 70 days after the last dose of study drug by visit or telephone.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
28
Faza
- Faza 3
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
15 lat i starsze (Dziecko, Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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).
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
|
Ampułko-strzykawka z adalimumabem, podawana we wstrzyknięciu podskórnym.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
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52 weeks
|
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Number of Participants With Potentially Significant Clinical Chemistry Parameters
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52
Ramy czasowe: 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.
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Baseline (Week 0) to Week 52
|
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Change in Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 52
Ramy czasowe: 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.
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Baseline (Week 0) to Week 52
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Dyrektor Studium: Morio Ozawa, MS, AbbVie GK.
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 września 2013
Zakończenie podstawowe (Rzeczywisty)
1 marca 2015
Ukończenie studiów (Rzeczywisty)
1 października 2015
Daty rejestracji na studia
Pierwszy przesłany
4 października 2013
Pierwszy przesłany, który spełnia kryteria kontroli jakości
7 października 2013
Pierwszy wysłany (Oszacować)
9 października 2013
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
12 kwietnia 2016
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
11 marca 2016
Ostatnia weryfikacja
1 marca 2016
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- M13-687
- 2015-004121-13 (Numer EudraCT)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .