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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01287897




Registration number
NCT01287897
Ethics application status
Date submitted
31/01/2011
Date registered
2/02/2011
Date last updated
21/01/2016

Titles & IDs
Public title
A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
Scientific title
A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)
Secondary ID [1] 0 0
2010-023034-23
Secondary ID [2] 0 0
B0151003
Universal Trial Number (UTN)
Trial acronym
ANDANTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-04236921 SC injection
Treatment: Drugs - PF-04236921 SC injection
Treatment: Drugs - PF-04236921 SC injection

Placebo comparator: Placebo- SC injection -

Experimental: Drug Dose level 1 - SC injection -

Experimental: Drug Dose level 2 - SC injection -


Treatment: Drugs: PF-04236921 SC injection
Placebo delivered SC, 2 doses separated by 4 weeks

Treatment: Drugs: PF-04236921 SC injection
Drug dose level 1 delivered SC, 2 doses separated by 4 weeks

Treatment: Drugs: PF-04236921 SC injection
Drug dose level 2 delivered SC, 2 doses separated by 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Crohn's Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Timepoint [1] 0 0
Baseline and Week 8
Primary outcome [2] 0 0
The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg
Timepoint [2] 0 0
Baseline and Week 8
Primary outcome [3] 0 0
The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Timepoint [3] 0 0
Baseline and Week 12
Primary outcome [4] 0 0
The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Timepoint [1] 0 0
Baseline and Weeks 2, 4, 6, and 10
Secondary outcome [2] 0 0
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Timepoint [2] 0 0
Baseline and Weeks 2, 4, 6, and 10
Secondary outcome [3] 0 0
The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Timepoint [3] 0 0
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Secondary outcome [4] 0 0
The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Timepoint [4] 0 0
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Secondary outcome [5] 0 0
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Timepoint [5] 0 0
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Secondary outcome [6] 0 0
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Timepoint [6] 0 0
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Secondary outcome [7] 0 0
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Timepoint [7] 0 0
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Secondary outcome [8] 0 0
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Timepoint [8] 0 0
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Secondary outcome [9] 0 0
Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)
Timepoint [9] 0 0
At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40
Secondary outcome [10] 0 0
Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)
Timepoint [10] 0 0
At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40
Secondary outcome [11] 0 0
Serum PF-04236921 Concentration Over Time
Timepoint [11] 0 0
Day 1 (predose), and at Weeks 2, 4 (Day 28, predose), 8, 10, 12, 16, 20, 24, 28, 32, 36, and 40
Secondary outcome [12] 0 0
Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs)
Timepoint [12] 0 0
Induction period: from Week 0 (Day 1) through Week 12; follow-up period: from Week 12 (or discontinuation from the induction period) through last subject visit (up to 28 weeks after completion of or discontinuation from the 12-week induction period)

Eligibility
Key inclusion criteria
* Subjects must have failed or are intolerant to anti TNFs
* hsCRP greater or equal to 5.0 mg/L
* Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed within 8 weeks of study entry (screening) and able to retrospectively complete the SES-CD or colonoscopy performed during screening
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or breastfeeding women
* Crohn's Disease with active fistulae or abscess
* History of diverticulitis or symptomatic diverticulosis
* Abnormality in hematology or chemistry profiles at screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2015
Sample size
Target
Accrual to date
Final
250
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Nepean Public Hospital - Kingswood
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston, Brisbane
Recruitment hospital [4] 0 0
Mater Health Services - South Brisbane
Recruitment hospital [5] 0 0
Eastern Health, Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [8] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
4029 - Herston, Brisbane
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
VIC 3065 - Fitzroy
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.
Trial website
https://clinicaltrials.gov/study/NCT01287897
Trial related presentations / publications
Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.
Danese S, Vermeire S, Hellstern P, Panaccione R, Rogler G, Fraser G, Kohn A, Desreumaux P, Leong RW, Comer GM, Cataldi F, Banerjee A, Maguire MK, Li C, Rath N, Beebe J, Schreiber S. Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II). Gut. 2019 Jan;68(1):40-48. doi: 10.1136/gutjnl-2017-314562. Epub 2017 Dec 15.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01287897