The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

• Register: EUCTR
• Last refreshed on: 4 August 2015
• Main ID: EUCTR2006-003399-37-NL
• Date of registration: 08/10/2007
• Prospective Registration: Yes
• Primary sponsor: Janssen Biologics BV
• Public title: The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis
• Scientific title: A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance
• Date of first enrolment: 17/01/2008
• Target sample size: 1350
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003399-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, India, Israel, Japan, Latvia, Lithuania, Netherlands, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Sweden, Ukraine, United States

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International N.V.

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International N.V.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Have received all study agent administrations and completed the Week 6 Mayo score evaluation in one of the induction studies of golimumab for UC (ie, C0524T16, EudraCT 2006-003397-94 or C0524T17, EudraCT 2006-003398-28).

2. Are able to complete the Week 0 visit on the same day as the Week 6 visit of the induction study C0524T16 or C0524T17.

3. During the study and for 6 months after receiving the last administration of study agent, women of childbearing potential or men capable of fathering children must agree to use adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization). Women of childbearing potential must test negative for pregnancy.

4. Must be able and willing to adhere to the study visit schedule and comply with other protocol requirements.

5. Are capable of providing informed consent, which must be obtained prior to any study-related procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion criteria:
1. Had any of the following changes to their concomitant UC medications (ie, oral 5 ASA compounds, oral corticosteroids, 6-MP, AZA, methotrexate [MTX]) since Week 0 of an induction study (C0524T16, EudraCT 2006-003397-94 or C0524T17, EudraCT 2006-003398-28):
a. an increased dose
b. initiation of a concomitant UC medication except for dose equivalent substitutions

2. Have received any of the following therapies since Week 0 of the induction study:
a. rectal corticosteroid therapy (ie, corticosteroids administered to the rectum or sigmoid colon via foam, enema, or suppository)
b. rectal 5-ASA compounds (ie, 5-ASA compounds administered to the rectum or sigmoid colon via foam, enema, or suppository)
c. parenteral corticosteroids
d. pentoxifylline
e. total parental nutrition (TPN)
f. antibiotics for the treatment of UC (including but not limited to ciprofloxacin, metronidazole, or rifaximin)
g. immunomodulatory agents other than 6-MP/AZA or MTX (including but not limited to 6-thioguanine [6-TG], cyclosporine, mycophenolate mofetil [MMF], tacrolimus, and sirolimus)
h. immunomodulatory biologic agents (including but not limited to infliximab, anakinra, etanercept, adalimumab, rituximab, natalizumab, visilizumab)
i. thalidomide or related agents
j. investigational drugs
k. apheresis (eg, Adacolumn apheresis)

3. Have had, in the opinion of the investigator, a clinically significant hypersensitivity reaction in an induction study (C0524T16 or C0524T17).

4. Have signs and symptoms of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis.

5. Have signs and symptoms of nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis).

6. Have had a clinically significant infection (eg, hepatitis, pneumonia, or pyelonephritis) or have received parenteral antibiotics for an infection since Week 0 of an induction study. Less serious infections (eg, acute upper respiratory tract infection, simple urinary tract infection) need not be considered exclusionary at the discretion of the investigator.

7. Have signs and symptoms of infection with HIV, hepatitis B, or hepatitis C.

8. Have signs and symptoms of any malignancy.

9. Have signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphoma or lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas), or clinically significant hepatomegaly or splenomegaly.

10. Have signs and symptoms of CHF, including medically controlled asymptomatic CHF.

11. Have signs and symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral diseases.

12. Have signs and symptoms of systemic lupus erythematosus.

13. Have signs and symptoms of demyelinating disease, such as multiple sclerosis or optic neuritis.

14. Have undergone a colectomy (partial or total) or an ostomy (ie, temporary colostomy, permanent colostomy, ileostomy, or other enterostomy) since Week 0 of the induction studies (C0524T16 or C0524T17).

15. Are pregnant or are planning pregnancy (both males and females) within 6 months following the last administration of study agent.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ulcerative Colitis (UC)
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO 148
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
Current Sponsor code: CNTO148
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: Evaluate the efficacy and safety of maintenance regimens of CNTO 148 (golimumab) in maintaining clinical response through Week 54

Secondary Objective: Evaluate the efficacy of CNTO 148 (golimumab) in maintaining clinical remission and mucosal healing at weeks 30 and 54, and in achieving clinical remission and eliminating corticosteroid use at Week 54 Evaluate the efficacy of golimumab in achieving clinical remission and eliminating corticosteroid use at Week 54 among subjects receiving concomitant corticosteroids at Week 0

Primary end point(s): The primary endpoint is clinical response through Week 54.

Timepoint(s) of evaluation of this end point: Week 54

Secondary Outcome(s)

Secondary end point(s): Evaluate the efficacy of CNTO 148 (golimumab) in maintaining clinical remission and mucosal healing at weeks 30 and 54, and in achieving clinical remission and eliminating corticosteroid use at Week 54.

Timepoint(s) of evaluation of this end point: Week 30 & 54

Secondary ID(s)

2006-003399-37-DE

C0524T18

Source(s) of Monetary Support

Janssen Research & Development