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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01458574




Registration number
NCT01458574
Ethics application status
Date submitted
21/10/2011
Date registered
25/10/2011
Date last updated
18/05/2017

Titles & IDs
Public title
A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis
Scientific title
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis
Secondary ID [1] 0 0
2011-004580-79
Secondary ID [2] 0 0
A3921096
Universal Trial Number (UTN)
Trial acronym
OCTAVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - CP690,550
Treatment: Drugs - CP-690,550

Placebo comparator: Placebo Comparator -

Experimental: CP-690,550 5 mg Arm -

Experimental: CP-690,550 10 mg Arm -


Treatment: Drugs: Placebo
Placebo 10 mg orally (PO) twice a day (BID)

Treatment: Drugs: CP690,550
CP-690,550 5 mg orally (PO) twice a day (BID)

Treatment: Drugs: CP-690,550
CP-690,550 10 mg orally (PO) twice a day (BID)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants In Remission at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Participants With Mucosal Healing at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline
Timepoint [2] 0 0
Week 24, 52
Secondary outcome [3] 0 0
Percentage of Participants in Remission at Week 24
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Percentage of Participants in Sustained Remission
Timepoint [4] 0 0
Week 24, 52
Secondary outcome [5] 0 0
Percentage of Participants With Mucosal Healing at Week 24
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
Percentage of Participants With Sustained Mucosal Healing
Timepoint [6] 0 0
Week 24, 52
Secondary outcome [7] 0 0
Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline
Timepoint [7] 0 0
Week 24, 52
Secondary outcome [8] 0 0
Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline
Timepoint [8] 0 0
Week 24, 52
Secondary outcome [9] 0 0
Percentage of Participants With Clinical Response at Week 24 and 52
Timepoint [9] 0 0
Week 24, 52
Secondary outcome [10] 0 0
Percentage of Participants With Sustained Clinical Response
Timepoint [10] 0 0
Week 24, 52
Secondary outcome [11] 0 0
Percentage of Participants in Clinical Remission at Week 24 and 52
Timepoint [11] 0 0
Week 24, 52
Secondary outcome [12] 0 0
Percentage of Participants in Sustained Clinical Remission
Timepoint [12] 0 0
Week 24, 52
Secondary outcome [13] 0 0
Percentage of Participants in Deep Remission at Week 24 and 52
Timepoint [13] 0 0
Week 24, 52
Secondary outcome [14] 0 0
Percentage of Participants in Sustained Deep Remission
Timepoint [14] 0 0
Week 24, 52
Secondary outcome [15] 0 0
Percentage of Participants in Symptomatic Remission at Week 24 and 52
Timepoint [15] 0 0
Week 24, 52
Secondary outcome [16] 0 0
Percentage of Participants in Sustained Symptomatic Remission
Timepoint [16] 0 0
Week 24, 52
Secondary outcome [17] 0 0
Percentage of Participants in Endoscopic Remission at Week 24 and 52
Timepoint [17] 0 0
Week 24, 52
Secondary outcome [18] 0 0
Percentage of Participants in Sustained Endoscopic Remission
Timepoint [18] 0 0
Week 24, 52
Secondary outcome [19] 0 0
Total Mayo Score at Baseline, Week 24 and 52
Timepoint [19] 0 0
Baseline, Week 24, 52
Secondary outcome [20] 0 0
Change From Baseline in Total Mayo Score at Week 24 and 52
Timepoint [20] 0 0
Baseline, Week 24, 52
Secondary outcome [21] 0 0
Percentage of Participants in Remission, Among Participants With Remission at Baseline
Timepoint [21] 0 0
Week 24, 52
Secondary outcome [22] 0 0
Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline
Timepoint [22] 0 0
Week 24, 52
Secondary outcome [23] 0 0
Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline
Timepoint [23] 0 0
Week 24, 52
Secondary outcome [24] 0 0
Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
Timepoint [24] 0 0
Week 24, 52
Secondary outcome [25] 0 0
Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
Timepoint [25] 0 0
Week 24, 52

Eligibility
Key inclusion criteria
* Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095
* Subjects who achieved clinical response in Study A3921094 or A3921095
* Women of childbearing potential must test negative for pregnancy prior to study enrollment
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
* Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095
* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
* Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.

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 3
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
20/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/05/2016
Sample size
Target
Accrual to date
Final
593
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Eastern Health-Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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Connecticut
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Kansas
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Maryland
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Michigan
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Minnesota
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New Hampshire
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Pennsylvania
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Utah
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Hradec Kralove
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Tallinn
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Estonia
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Tallin
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Halle
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Wellington
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Iodzkie
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Mazowieckie
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Slaskie
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Bydgoszcz
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Wroclaw
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Timis
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Bucuresti
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Russian Federation
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Russian Federation
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk,
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Russian Federation
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Novosibirsk
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Russian Federation
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Samara
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Russian Federation
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Yaroslavl
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Serbia
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Serbia, Europe
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Novi Sad
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Serbia
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Zrenjanin
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Slovakia
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Bratislava
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Slovakia
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Nitra
Country [125] 0 0
Slovakia
State/province [125] 0 0
Nove Mesto nad Vahom
Country [126] 0 0
Slovakia
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Presov
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South Africa
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Cape Town
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South Africa
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Gauteng
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South Africa
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Western Cape
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Spain
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Barcelona
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Spain
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Madrid
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Taiwan
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Taipei City
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Ukraine
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Ar Krym
Country [134] 0 0
Ukraine
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Chernivtsi
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Ukraine
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Dniepropetrovsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Uzhgorod
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhzhia
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United Kingdom
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Cambridgeshire
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United Kingdom
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England
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United Kingdom
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Greater London
Country [146] 0 0
United Kingdom
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Middlesex
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Norfolk
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.
Trial website
https://clinicaltrials.gov/study/NCT01458574
Trial related presentations / publications
Lichtenstein GR, Bressler B, Francisconi C, Vermeire S, Lawendy N, Salese L, Sawyerr G, Shi H, Su C, Judd DT, Jones T, Loftus EV. Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):27-41. doi: 10.1093/ibd/izac084.
Hudesman DP, Torres J, Salese L, Woolcott JC, Mundayat R, Su C, Mosli MH, Allegretti JR. Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program. Patient. 2023 Mar;16(2):95-103. doi: 10.1007/s40271-022-00603-w. Epub 2022 Nov 7.
Winthrop KL, Vermeire S, Long MD, Panes J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2023 Jan 5;29(1):85-96. doi: 10.1093/ibd/izac063.
Vavricka SR, Greuter T, Cohen BL, Reinisch W, Steinwurz F, Fellmann M, Guo X, Lawendy N, Paulissen J, Peyrin-Biroulet L. Corticosteroid-free efficacy and safety outcomes in patients receiving tofacitinib in the OCTAVE Sustain maintenance study. Therap Adv Gastroenterol. 2022 May 10;15:17562848221090834. doi: 10.1177/17562848221090834. eCollection 2022.
Mukherjee A, Tsuchiwata S, Nicholas T, Cook JA, Modesto I, Su C, D'Haens GR, Sandborn WJ. Exposure-Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies. Clin Pharmacol Ther. 2022 Jul;112(1):90-100. doi: 10.1002/cpt.2601. Epub 2022 Apr 27.
Feagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.
Farraye FA, Qazi T, Kotze PG, Moore GT, Mundayat R, Lawendy N, Sharma PP, Judd DT. The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme. Aliment Pharmacol Ther. 2021 Aug;54(4):429-440. doi: 10.1111/apt.16439. Epub 2021 Jun 24.
Rubin DT, Reinisch W, Greuter T, Kotze PG, Pinheiro M, Mundayat R, Maller E, Fellmann M, Lawendy N, Modesto I, Vavricka SR, Lichtenstein GR. Extraintestinal manifestations at baseline, and the effect of tofacitinib, in patients with moderate to severe ulcerative colitis. Therap Adv Gastroenterol. 2021 May 16;14:17562848211005708. doi: 10.1177/17562848211005708. eCollection 2021.
Panes J, Vermeire S, Dubinsky MC, Loftus EV, Lawendy N, Wang W, Salese L, Su C, Modesto I, Guo X, Colombel JF. Efficacy and Safety of Tofacitinib Re-treatment for Ulcerative Colitis After Treatment Interruption: Results from the OCTAVE Clinical Trials. J Crohns Colitis. 2021 Nov 8;15(11):1852-1863. doi: 10.1093/ecco-jcc/jjab065.
Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.
Vong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.
Curtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan(R) Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.
Colombel JF, Osterman MT, Thorpe AJ, Salese L, Nduaka CI, Zhang H, Lawendy N, Friedman GS, Quirk D, Su C, Reinisch W. Maintenance of Remission With Tofacitinib Therapy in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):116-125.e5. doi: 10.1016/j.cgh.2020.10.004. Epub 2020 Oct 9.
Sands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.
Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2021 Sep;66(9):3214-3215. doi: 10.1007/s10620-020-06638-z.
Lichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panes J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.
Sandborn WJ, Panes J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.
Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.
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Panes J, Vermeire S, Lindsay JO, Sands BE, Su C, Friedman G, Zhang H, Yarlas A, Bayliss M, Maher S, Cappelleri JC, Bushmakin AG, Rubin DT. Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies. J Crohns Colitis. 2018 Jan 24;12(2):145-156. doi: 10.1093/ecco-jcc/jjx133. Erratum In: J Crohns Colitis. 2019 Jan 1;13(1):139-140. doi: 10.1093/ecco-jcc/jjy135.
Sandborn WJ, Su C, Sands BE, D'Haens GR, Vermeire S, Schreiber S, Danese S, Feagan BG, Reinisch W, Niezychowski W, Friedman G, Lawendy N, Yu D, Woodworth D, Mukherjee A, Zhang H, Healey P, Panes J; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017 May 4;376(18):1723-1736. doi: 10.1056/NEJMoa1606910.
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01458574