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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 7 January 2019
Main ID:  EUCTR2017-004496-31-BE
Date of registration: 25/07/2018
Prospective Registration: Yes
Primary sponsor: Janssen Biologics BV
Public title: A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis
Scientific title: A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2
Date of first enrolment: 07/11/2018
Target sample size: 125
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004496-31
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Belgium Brazil France Israel Italy Korea, Republic of Netherlands Poland
Spain Taiwan United States
Contacts
Name: Clinical Registry Group   
Address:  Janssen Biologics BV - Archimedesweg 29 2333 CM Leiden Netherlands
Telephone:
Email: ClinicalTrialsEU@its.jnj.com
Affiliation:  Janssen Biologics BV
Name: Clinical Registry Group   
Address:  Janssen Biologics BV - Archimedesweg 29 2333 CM Leiden Netherlands
Telephone:
Email: ClinicalTrialsEU@its.jnj.com
Affiliation:  Janssen Biologics BV
Key inclusion & exclusion criteria
Inclusion criteria:
1. Must be 2 to 17 years of age (at the time of the first administration of
study intervention at Week 0) of either gender with a body weight =10
kg and >70 cm height.
2. Must have had UC diagnosed for at least 1 month prior to screening.
3. Must have the diagnosis of UC confirmed by a prior endoscopic biopsy
that is consistent with a diagnosis of UC (eg, crypt distortion, crypt
abscess, goblet cell depletion, and continuous distribution).
4. Must have moderately to severely active UC (as defined by baseline
Mayo score of 6 through 12 [endoscopy {sigmoidoscopy or colonoscopy}
subscore assigned by local endoscopist], inclusive).
5. Must have a Mayo endoscopy (sigmoidoscopy or colonoscopy)
subscore =2 (subscore assigned by local endoscopist) at baselineendoscopy (indicative of moderately to severely active UC). Baseline
endoscopy (sigmoidoscopy or colonoscopy) must be performed with
study software and occur no more than 2 weeks before first study
intervention administration.
6. Prior or current medication for UC must include at least 1 of the
following (Appendix 2 [Section 10.2]):
a. Current treatment with at least 1 of the following therapies: oral or
intravenous corticosteroids, or the immunomodulators 6-MP or AZA.
OR
b. Have a history of failure to respond to or tolerate, or have a medical
contraindication to, at least 1 of the following therapies: oral or
intravenous corticosteroids or the immunomodulators 6-MP or AZA.
OR
c. Currently have or have had a history of corticosteroid dependency (ie,
an inability to successfully taper corticosteroids without a return of the
symptoms of UC).
OR
d. Have required more than 3 courses of oral or intravenous
corticosteroids in the past year.
7. Must meet concomitant medication stability criteria prior to the first
administration of study intervention.
8. If receiving parenteral or enteral nutrition, must have been on a
stable regimen for at least 2 weeks prior to the first administration of
study intervention at Week 0.
9. Must have discontinued the use of antibiotics for the treatment of UC
(eg, ciprofloxacin, metronidazole, or rifaximin) for at least 1 week prior
to screening.
10. Must have discontinued the use of 6-thioguanine (6-TG) for at least 4
weeks prior to screening.
11. If at increased risk for colon cancer, must either have had a
colonoscopy to assess the presence of dysplasia within 1 year prior to
the first administration of study intervention at Week 0 or a colonoscopy
to assess the presence of malignancy as the baseline endoscopy.
Baseline endoscopy (sigmoidoscopy or colonoscopy) must be performed
with study software and occur no more than 2 weeks before first study
intervention administration.
12. Before randomization, a girl must be either:
a. Not of childbearing potential defined as:
1) Premenarchal
2) Permanently sterile
b. Of childbearing potential and
1) Practicing a highly effective method of contraception (failure rate of
<1% per year when used consistently and correctly) during the study
and for 6 months after receiving the last dose of study intervention. Both
user-independent and user-dependent methods of contraception are
allowed.
13. Boys must agree not to donate sperm for the purpose of reproduction
during the study and for a minimum 6 months after receiving the last
dose of study intervention.
14. All girls of childbearing potential must have a negative serum
pregnancy test at screening.
15. A girl of ch

Exclusion criteria:
1. Have severe, extensive colitis as evidenced by:
a. Investigator judgment that the participant is likely to require a
colectomy within 12 weeks of Week 0.
OR
b. Symptom complex at screening or Week 0 visit that includes at least 4
of the following:
1) Diarrhea with =6 bowel movements/day with macroscopic blood in
stool
2) Focal severe or rebound abdominal tenderness
3) Persistent fever (=37.5°C) for more than 5 days
4) Persistent tachycardia for more than 5 days
5) Anemia (hemoglobin < 8.5 g/dL)
2. Participants with very severe active UC disease who are currently
hospitalized for UC disease exacerbation when initiating study screening
and who have a Mayo score of 12 should be excluded from the study.
3. History of liver or renal insufficiency; significant cardiac, vascular,
pulmonary, gastrointestinal, endocrine, neurologic, hematologic,
rheumatologic, psychiatric (including suicidality), or metabolic
disturbances.
4. History of malignancy or macrophage activation syndrome (MAS) or
hemophagocytic lymphohistiocytosis (HLH).
5. A serious allergic reaction to latex.
6. Contraindications to the use of golimumab or infliximab or anti-TNFa
therapy per local prescribing information.
7. Taken any disallowed therapies as noted in Section 6.5, Concomitant
Therapy before the planned first dose of study intervention.
8. Received an investigational vaccine or used an invasive investigational
medical device within 3 months before the planned first dose of study
intervention or is currently enrolled in an investigational study.
9. Pregnant, or breast-feeding, or planning to become pregnant while
enrolled in this study or within 6 months after the last dose of study
intervention.
10. Plans to father a child while enrolled in this study or within 6 months
after the last dose of study intervention.
11. Any condition for which, in the opinion of the investigator,
participation would not be in the best interest of the participant (eg,
compromise the well-being) or that could prevent, limit, or confound the
protocol-specified assessments
12. Had major surgery, (eg, requiring general anesthesia) within 3 months before screening, or will not have fully recovered from surgery,
or has surgery planned during the time the participant is expected to
participate in the study or within 3 months after the last dose of study
intervention administration.
13. Have UC limited to the rectum only or to <20% of the colon.
14. Presence of a stoma.
15. Presence or history of a fistula.
16. Have severe, fixed symptomatic stenosis of the large or small
intestine.
17. Require, or required within the 2 months prior to screening, surgery
for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or
intra-abdominal or pancreatic abscess requiring surgical drainage, or
other conditions possibly confounding the evaluation of benefit from
study intervention treatment.
18. Presence or history of colonic or small bowel obstruction within 6
months prior to screening, confirmed by objective radiographic or
endoscopic evidence of a stricture with resulting obstruction (dilation of
the colon or small bowel proximal to the stricture on barium radiograph
or an inability to traverse the stricture at endoscopy).
19. History of extensive colonic resection (eg, less than 30 cm of colon
remaining) that would prevent adequate evaluation of the effect of study
intervention on clinical disease activity.
20. Presence on scr


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Ulcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Intervention(s)

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: Golimumab
Product Code: CNTO148
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 45/0.45-

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Remicade
Product Name: Infliximab
Pharmaceutical Form: Powder for concentrate and solution for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 5-10

Primary Outcome(s)
Main Objective: •To evaluate the efficacy of golimumab in inducing clinical remission as
assessed by the Mayo score, in pediatric participants with moderately to
severely active UC.
•To evaluate the safety profile of golimumab, in pediatric participants
with moderately to severely active UC.
Primary end point(s): The primary endpoint is clinical remission as assessed by the Mayo
score.
Secondary Objective: •To evaluate the efficacy of golimumab in inducing clinical response as
assessed by the Mayo Score and clinical remission as measured by the
PUCAI Score.
•To evaluate the efficacy of golimumab on endoscopic healing.
•To evaluate the efficacy of golimumab during the long-term phase.
•To evaluate the effect of golimumab on additional efficacy and quality
of life (QOL) measures
•To evaluate the PK and exposure response of golimumab during shortand
long-term phases.
Timepoint(s) of evaluation of this end point: Week 6
Secondary Outcome(s)
Secondary end point(s): 1. Clinical response as assessed by the Mayo score (based on Mayo
endoscopy subscore assigned by the local endoscopist).
2. Clinical remission as assessed by the PUCAI score.
3. Endoscopic healing (based on Mayo endoscopy subscore assigned by
the local endoscopist).
4. Clinical remission as assessed by the PUCAI score.
5. Endoscopic healing (based on Mayo endoscopy subscore assigned by
the local endoscopist).
Timepoint(s) of evaluation of this end point: 1. Week 6
2. Week 6
3. Week 6
4. Week 54
5. Week 54
Secondary ID(s)
CNTO148UCO3003
Source(s) of Monetary Support
Janssen Research & Development
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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