Clinical trial NCT02407236: A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colitis, Ulcerative
Inflammatory Bowel Diseases
Keywords: Ustekinumab
Inflammatory Bowel Diseases (IBD)
Colitis, Ulcerative
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2015-04-02
Enrollment: 961
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

Detailed description: This is a Phase 3, randomized (assignment of study drug by chance), double-blind (neither the participant or study staff will know the identity of study drugs), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions), multi-center (more than one clinical site will work on a medical research study), protocol of ustekinumab. The protocol will consist of 2 studies: an Induction study and a Maintenance study with unique endpoints. Screening period will be up to 8 Weeks. Induction study will be at least 8 weeks duration for each participant. Participant with clinical response in the Induction study will be eligible for the Maintenance study. The Maintenance study will be 44 weeks duration. After completion of the maintenance study, a long term extension will follow eligible participants for an additional 3 years. Clinical remission will be evaluated at Week 8 in the Induction study. Clinical remission among ustekinumab Induction responders will be evaluated at week 44 in the Maintenance study. Participants' safety will be monitored throughout.

Eligibility criteria: Inclusion Criteria:

* Has a clinical diagnosis of Ulcerative Colitis (UC) at least 3 months before Screening
* Has moderately to severely active UC, defined as a Baseline (Week 0) Mayo score of 6 to 12, including a Screening endoscopy subscore of the Mayo score greater than or equal to (\>=) 2 as determined by a central reading of the video endoscopy
* Have failed biologic therapy, that is, have received treatment with 1 or more tumour necrosis factor (TNF) antagonists or vedolizumab at a dose approved for the treatment of UC, and have a documented history of failure to respond to or tolerate such treatment; OR Be naïve to biologic therapy (TNF antagonists or vedolizumab) or have received biologic therapy but have not demonstrated a history of failure to respond to, or tolerate, a biologic therapy and have a prior or current UC medication history that includes at least 1 of the following: a. Inadequate response to or failure to tolerate current treatment with oral corticosteroids or immunomodulators (6-mercaptopurine \[6-MP\] or azathioprine \[AZA\]) OR b. History of failure to respond to, or tolerate, at least 1 of the following therapies: oral or IV corticosteroids or immunomodulators (6-MP or AZA) OR c. History of corticosteroid dependence (that is, an inability to successfully taper corticosteroids without a return of the symptoms of UC)
* Before the first administration of study agent, the following conditions must be met: vedolizumab must have been discontinued for at least 4 months and anti-tumor necrosis factors (TNFs) for at least 8 weeks

Exclusion Criteria:

* Has severe extensive colitis and is at imminent risk of colectomy
* Has UC limited to the rectum only or to \< 20 centimeters (cm) of the colon
* Presence of a stoma or history of a fistula
* Participants with history of extensive colonic resection (for example, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity
* Participants with history of colonic mucosal dysplasia. Participants will not be excluded from the study because of a pathology finding of "indefinite dysplasia with reactive atypia''

Primary outcomes:
measure: Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition)
timeFrame: Week 8
measure: Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per US Definition)
timeFrame: Week 8
measure: Maintenance Study: Number of Participants With Clinical Remission at Week 44 (As Per Global Definition)
timeFrame: Week 44
measure: Maintenance Study: Number of Participants With Clinical Remission at Week 44 (as Per US Definition)
timeFrame: Week 44
Secondary outcomes:
measure: Induction Study: Number of Participants With Endoscopic Healing at Week 8
timeFrame: Week 8
measure: Induction Study: Number of Participants With Clinical Response at Week 8
timeFrame: Week 8
measure: Induction Study - Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
timeFrame: Baseline and Week 8
measure: Maintenance Study: Number of Participants With Clinical Response up to Week 44
timeFrame: Up to Week 44
measure: Maintenance Study: Number of Participants With Endoscopic Healing at Week 44
timeFrame: Week 44
measure: Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per Global Definition)
timeFrame: Week 44
measure: Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per US Definition)
timeFrame: Week 44
measure: Maintenance Study: Number of Participants With Clinical Remission up to Week 44 Among Participants Who Achieved Clinical Remission at Maintenance Study Baseline (As Per Global Definition)
timeFrame: Up to Week 44
measure: Maintenance Study: Number of Participants With Clinical Remission up to Week 44 Among Participants Who Achieved Clinical Remission at Maintenance Study Baseline (As Per US Definition)
timeFrame: Up to Week 44
measure: Induction Study - Number of Participants With Mucosal Healing at Week 8
timeFrame: Week 8
measure: Induction Study - Number of Participants in Clinical Remission With a Rectal Bleeding Subscore of 0 at Week 8 (As Per Global Definition)
timeFrame: Week 8
measure: Induction Study - Number of Participants in Symptomatic Remission at Week 8
timeFrame: Week 8
measure: Induction Study - Number of Participants in With Normal or Inactive Mucosal Disease at Week 8
timeFrame: Week 8
measure: Induction Study - Change From Baseline in Mayo Score at Week 8
timeFrame: Baseline and Week 8
measure: Induction Study - Change From Baseline in Partial Mayo Score Through Week 8
timeFrame: Baseline through Week 8
measure: Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8
timeFrame: Up to Week 8
measure: Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8
timeFrame: Up to Week 8
measure: Induction Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 8
timeFrame: Week 8
measure: Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8
timeFrame: Up to Week 8
measure: Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per Global Definition)
timeFrame: Week 8
measure: Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per US Definition)
timeFrame: Week 8
measure: Induction Study - Number of Participants With Endoscopic Healing at Week 8 by Biologic Failure Status
timeFrame: Week 8
measure: Induction Study - Number of Participants With Clinical Response at Week 8 by Biologic Failure Status
timeFrame: Week 8
measure: Induction Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)
timeFrame: Week 8
measure: Induction Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)
timeFrame: Week 8
measure: Induction Study - Change From Baseline in C-reactive Protein (CRP) Concentration Through Week 8
timeFrame: Baseline through Week 8
measure: Induction Study - Number of Participants With Normalized CRP (<=3 mg/L) up to Week 8 Among Participants With Abnormal CRP (>3 mg/L) at Baseline
timeFrame: Up to Week 8
measure: Induction Study - Change From Baseline in Fecal Lactoferrin Concentration Through Week 8
timeFrame: Baseline through Week 8
measure: Induction Study - Number of Participants With Normalized Fecal Lactoferrin (<=7.24 mcg/g) up to Week 8 Among Participants With Abnormal Fecal Lactoferrin (>7.24 mcg/g) at Baseline
timeFrame: Up to Week 8
measure: Induction Study - Change From Baseline in Fecal Calprotectin Concentration Through Week 8
timeFrame: Baseline through Week 8
measure: Induction Study - Number of Participants With Normalized Fecal Calprotectin (<=250 mg/kg) up to Week 8 Among Participants With Abnormal Fecal Calprotectin (>250 mg/kg) at Baseline
timeFrame: Up to Week 8
measure: Induction Study - Number of Participants With a >20-point Improvement From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
timeFrame: Baseline and Week 8
measure: Induction Study - Change From Baseline in IBDQ Dimension Scores at Week 8
timeFrame: Baseline and Week 8
measure: Induction Study - Change From Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Week 8
timeFrame: Baseline and Week 8
measure: Induction Study - Change From Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8
timeFrame: Baseline and Week 8
measure: Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Week 8
timeFrame: Baseline and Week 8
measure: Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health State Visual Analog Scale (VAS) Score at Week 8
timeFrame: Baseline and Week 8
measure: Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8
timeFrame: Baseline and Week 8
measure: Maintenance Study - Change From Maintenance Baseline in Mayo Score at Week 44
timeFrame: Baseline and Week 44
measure: Maintenance Study - Change From Induction Baseline in Mayo Score at Week 44
timeFrame: Induction Baseline and Week 44
measure: Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44
timeFrame: Up to Week 44
measure: Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44
timeFrame: Up to Week 44
measure: Maintenance Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 44
timeFrame: Week 44
measure: Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44
timeFrame: Up to Week 44
measure: Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44
timeFrame: Baseline through Week 44
measure: Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44
timeFrame: Baseline through Week 44
measure: Maintenance Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 44
timeFrame: Week 44
measure: Maintenance Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 44
timeFrame: Week 44
measure: Maintenance Study: Number of Participants in Symptomatic Remission at Week 44
timeFrame: Week 44
measure: Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per Global Definition)
timeFrame: Week 44
measure: Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per US Definition)
timeFrame: Week 44
measure: Maintenance Study: Number of Participants With Clinical Response up to Week 44 by Biologic Failure Status
timeFrame: Up to Week 44
measure: Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 by Biologic Failure Status
timeFrame: Week 44
measure: Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 Among Participants Who Had Achieved Endoscopic Healing at Maintenance Baseline
timeFrame: Week 44
measure: Maintenance Study: Number of Participants With Normal or Inactive Mucosal Disease at Week 44
timeFrame: Week 44
measure: Maintenance Study: Number of Participants With Clinical Remission at Week 44 and Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline (Per Global Definition)
timeFrame: Week 44
measure: Maintenance Study: Number of Participants With Clinical Remission at Week 44 and Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline (Per US Definition)
timeFrame: Week 44
measure: MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline
timeFrame: Baseline Through Week 44
measure: Maintenance Study: Number of Participants Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline
timeFrame: Week 44
measure: Maintenance Study: Number of Participants Who Maintained 20-point Improvement From Induction Baseline in IBDQ up to Week 44 Among Participants With a >20-point Improvement in IBDQ at Maintenance Baseline
timeFrame: Up to Week 44
measure: Maintenance Study: Change From Maintenance Baseline in the IBDQ Score at Week 20 and 44
timeFrame: Baseline, Week 20, and 44
measure: Maintenance Study: Change From Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44
timeFrame: Baseline, Week 20, and 44
measure: Maintenance Study: Change From Maintenance Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Weeks 20 and 44
timeFrame: Baseline, Weeks 20, and 44
measure: Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44
timeFrame: Baseline, Weeks 20, and 44
measure: Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Weeks 20 and 44
timeFrame: Baseline, Weeks 20, and 44
measure: Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Health State Visual Analog Scale (VAS) Score at Weeks 20 and 44
timeFrame: Baseline, Weeks 20 and 44
measure: Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44
timeFrame: Baseline, Weeks 20, and 44
measure: Maintenance Study: Number of Participants With Mucosal Healing at Week 44
timeFrame: Week 44
measure: Maintenance Study: Change From Maintenance Baseline in C-reactive Protein (CRP) Concentration at Weeks 8, 24, and 44
timeFrame: Baseline, Weeks 8, 24, and 44
measure: Maintenance Study: Change From Maintenance Baseline in Fecal Lactoferrin Concentration at Weeks 8, 24, and 44
timeFrame: Baseline, Weeks 8, 24, and 44
measure: Maintenance Study: Change From Maintenance Baseline in Fecal Calprotectin Concentration at Weeks 8, 24, and 44
timeFrame: Baseline, Weeks 8, 24, and 44
Other outcomes:
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country: Hungary
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city: Haifa
country: Israel
city: Holon
country: Israel
city: Jerusalem
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country: Israel
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country: Israel
city: Petach Tikvah
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country: Israel
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country: Israel
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country: Japan
city: Asahikawa
country: Japan
city: Bunkyo Ku
country: Japan
city: Chiba
country: Japan
city: Chikushinoshi
country: Japan
city: Fujiidera
country: Japan
city: Fukuoka-ken
country: Japan
city: Higashi-Ibaraki
country: Japan
city: Hirosaki
country: Japan
city: Hiroshima
country: Japan
city: Isesaki
country: Japan
city: Iwate
country: Japan
city: Izumo
country: Japan
city: Kagoshima
country: Japan
city: Kahoku
country: Japan
city: Kobe-shi
country: Japan
city: Kochi
country: Japan
city: Kurume
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city: Kyoto
country: Japan
city: Midori-ku
country: Japan
city: Nagasaki
country: Japan
city: Nara
country: Japan
city: Nishinomiya
country: Japan
city: Oita
country: Japan
city: Osaka
country: Japan
city: Saga-ken
country: Japan
city: Saga
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city: Sapporo
country: Japan
city: Sendai
country: Japan
city: Shizuoka
country: Japan
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country: Japan
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country: Japan
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country: Japan
city: Tokyo
country: Japan
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country: Japan
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country: Japan
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country: Japan
city: Tsu
country: Japan
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country: Japan
city: Yamanashi
country: Japan
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city: Guri-si
country: Korea, Republic of
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city: Suwon-si
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country: Netherlands
city: Maastricht
country: Netherlands
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country: New Zealand
city: Christchurch
country: New Zealand
city: Dunedin
country: New Zealand
city: Lower Hutt
country: New Zealand
city: Milford
country: New Zealand
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country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Pulawy
country: Poland
city: Sopot
country: Poland
city: Szczecin
country: Poland
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country: Romania
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city: Kazan
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city: Moscow
country: Russian Federation
city: Moscva
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Rostov-on-Don
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St.-Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Ufa
country: Russian Federation
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Nis
country: Serbia
city: Vojvodina
country: Serbia
city: Bratislava
country: Slovakia
city: Presov
country: Slovakia
city: Chernivtsi
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiyv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Sumy
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Zaporizhzhia
country: Ukraine
city: Zhaporozhia
country: Ukraine
city: Birmingham
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Coventry
country: United Kingdom
city: Doncaster
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Salford
country: United Kingdom
city: Southampton
country: United Kingdom
city: Sutton In Ashfield
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Danese S, Sands BE, Abreu MT, O'Brien CD, Bravata I, Nazar M, Miao Y, Wang Y, Rowbotham D, Leong RWL, Arasaradnam RP, Afif W, Marano C. Early Symptomatic Improvement After Ustekinumab Therapy in Patients With Ulcerative Colitis: 16-Week Data From the UNIFI Trial. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2858-2867.e5. doi: 10.1016/j.cgh.2022.02.050. Epub 2022 Mar 8.
citation: Panaccione R, Danese S, Sandborn WJ, O'Brien CD, Zhou Y, Zhang H, Adedokun OJ, Tikhonov I, Targan S, Abreu MT, Hisamatsu T, Scherl EJ, Leong RW, Rowbotham DS, Arasaradnam RP, Sands BE, Marano C. Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy. Aliment Pharmacol Ther. 2020 Dec;52(11-12):1658-1675. doi: 10.1111/apt.16119. Epub 2020 Oct 21.
citation: Sandborn WJ, Feagan BG, Danese S, O'Brien CD, Ott E, Marano C, Baker T, Zhou Y, Volger S, Tikhonov I, Gasink C, Sands BE, Ghosh S. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):994-1007. doi: 10.1093/ibd/izaa236.
citation: Li K, Marano C, Zhang H, Yang F, Sandborn WJ, Sands BE, Feagan BG, Rubin DT, Peyrin-Biroulet L, Friedman JR, De Hertogh G. Relationship Between Combined Histologic and Endoscopic Endpoints and Efficacy of Ustekinumab Treatment in Patients With Ulcerative Colitis. Gastroenterology. 2020 Dec;159(6):2052-2064. doi: 10.1053/j.gastro.2020.08.037. Epub 2020 Aug 25.
citation: Sands BE, Sandborn WJ, Panaccione R, O'Brien CD, Zhang H, Johanns J, Adedokun OJ, Li K, Peyrin-Biroulet L, Van Assche G, Danese S, Targan S, Abreu MT, Hisamatsu T, Szapary P, Marano C; UNIFI Study Group. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1201-1214. doi: 10.1056/NEJMoa1900750.