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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
Studie Overzicht
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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.
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Adalimumab voorgevulde spuit, toegediend via subcutane injectie.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8
Tijdsspanne: 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.
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Week 8
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Tijdsspanne: 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
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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
Tijdsspanne: 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
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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
Tijdsspanne: 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
Tijdsspanne: 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
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C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
Tijdsspanne: 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.
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Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Number of Participants With Potentially Significant Hematology Parameters
Tijdsspanne: 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
Tijdsspanne: 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.
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52 weeks
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Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Tijdsspanne: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Blood pressure was measured while the participant was sitting.
n=the number of participants with available data at each time point.
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Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Tijdsspanne: 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.
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Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Tijdsspanne: 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.
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Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
Tijdsspanne: 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.
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Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Number of Participants With Adverse Events (AEs)
Tijdsspanne: 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
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52
Tijdsspanne: 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
Tijdsspanne: Baseline (Week 0) to Week 52
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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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Morio Ozawa, MS, AbbVie GK.
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- M13-687
- 2015-004121-13 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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