- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00584740
Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease
24. mars 2015 oppdatert av: Novartis Pharmaceuticals
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Assess the Efficacy, Safety and Tolerability of Two Single iv Infusions of AIN457 10 mg/kg (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Active Crohn's Disease
This study will assess the safety and efficacy of AIN457 in patients with moderate to severe active Crohn's disease.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
59
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Berlin, Tyskland, 10117
- Novartis Investigative Site
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Stuttgart, Tyskland, 70376
- Novartis Investigative Site
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Male or female; 18-75 years old
- Diagnosis of Crohn's disease for at least 3 months prior to screening
- Confirmation of Crohn's disease by endoscopic or imaging examination
- Moderately active Crohn's disease at baseline, defined as:
- CDAI ≥220 and ≤450
- Active disease despite prior treatment with corticosteroids for at least 2 weeks, or immunosuppressants for at least 3 months. Treatment with azathioprine, 6-MP or MTX is allowed but must have been on a stable dose for at least 10 weeks, corticosteroids are allowed but must have been on a stable doses of prednisolone not exceeding 40 mg for two weeks prior to baseline. Immunosuppressants other than those listed above, such as cyclosporine, tacrolimus and mycophenolate, are not allowed and must be stopped (wash-out periods defined in the protocol);
Exclusion Criteria:
- Body Mass Index >34
- Positive PPD tuberculin skin test or QuantiFeron test
- Any subject with evidence of active pulmonary disease or evidence of latent tuberculosis or fungal infection at screening or within past 3 months
- Symptoms associated with active bowel structuring disease and pre-stenotic dilation on radiographs
- Fistulizing disease if complicated by sepsis and/or untreated abscess
- Multiple bowel surgeries and clinically important short bowel syndrome defined as an inability to maintain caloric intake
- Use of certain medications as specified in the protocol
- Clinical improvement due to other Crohn's therapy
Other protocol-defined inclusion/exclusion criteria may apply
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: AIN457
AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
|
10 mg/kg
|
Placebo komparator: Placebo
Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
|
Matcher placebo med AIN457
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score
Tidsramme: 6 weeks
|
The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease.
Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis.
In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight.
The CDAI score is the sum of the products of each item multiplied by its weighting factor.
CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450.
A negative change in mean score indicates improvement.
|
6 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants Achieving Remission and/or Response
Tidsramme: 6 weeks
|
Remission or response was defined as CDAI < 150 points or CDAI reduction from baseline of at least 70 points.
|
6 weeks
|
Percentage of Participants Achieving Remission
Tidsramme: 6 weeks
|
Remission was defined as CDAI < 150 points.
|
6 weeks
|
Percentage of Participants Achieving Response
Tidsramme: 6 weeks
|
Response was defined as CDAI reduction of at least 70 points from baseline.
|
6 weeks
|
Mean Change From Baseline in CDAI Score
Tidsramme: baseline, 2 weeks, 4 weeks
|
The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease.
Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis.
In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight.
The CDAI score is the sum of the products of each item multiplied by its weighting factor.
CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450.
A negative change in mean score indicates improvement.
|
baseline, 2 weeks, 4 weeks
|
Area Under CDAI Curve
Tidsramme: 10 weeks
|
The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease.
Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis.
In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight.
The CDAI score is the sum of the products of each item multiplied by its weighting factor.
CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450.
An area under the CDAI response curve analysis was performed with a starting point from week 4.
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10 weeks
|
Percentage of Participants Maintaining Remission
Tidsramme: 10 weeks
|
Remission was defined as CDAI < 150 points.
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10 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2008
Primær fullføring (Faktiske)
1. august 2010
Studiet fullført (Faktiske)
1. august 2010
Datoer for studieregistrering
Først innsendt
21. desember 2007
Først innsendt som oppfylte QC-kriteriene
21. desember 2007
Først lagt ut (Anslag)
2. januar 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
31. mars 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. mars 2015
Sist bekreftet
1. mars 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CAIN457A2202
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