- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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
A tanulmány áttekintése
Részletes leírás
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- 3. fázis
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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).
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Kísérleti: 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 előretöltött fecskendő, szubkután injekcióban beadva.
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8
Időkeret: Week 8
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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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Időkeret: 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
Időkeret: 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.
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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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 52 weeks
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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
Időkeret: 52 weeks
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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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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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)
Időkeret: 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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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi igazgató: Morio Ozawa, MS, AbbVie GK.
Publikációk és hasznos linkek
Hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- M13-687
- 2015-004121-13 (EudraCT szám)
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
Klinikai vizsgálatok a Crohn-betegség
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National Institute of Allergy and Infectious Diseases...MegszűntKrónikus granulomatózisos betegség | Gyulladásos bélbetegség (IBD) | Crohn'S-szerű IBDEgyesült Államok
Klinikai vizsgálatok a Adalimumab
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PfizerBefejezveEgészségesEgyesült Államok, Belgium
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PfizerBefejezveEgészséges alanyokEgyesült Államok
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AbbottVisszavont
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Mylan Inc.Mylan GmbHBefejezvePikkelysömör | Ízületi gyulladás, pikkelysömörBulgária, Észtország, Magyarország, Lengyelország, Orosz Föderáció, Ukrajna
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AbbottBefejezveRheumatoid arthritisSpanyolország
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AbbottBefejezveArthritis, juvenilis idiopátiásEgyesült Államok, Belgium, Cseh Köztársaság, Franciaország, Németország, Olaszország, Szlovákia, Spanyolország
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Shanghai Henlius BiotechBefejezve
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Turgut İlaçları A.Ş.BefejezveEgészséges résztvevőkNémetország
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AbbottBefejezveCrohn-betegségEgyesült Államok
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AbbVie (prior sponsor, Abbott)BefejezveRheumatoid arthritisEgyesült Államok, Belgium, Cseh Köztársaság, Németország, Puerto Rico, Románia, Szlovákia