Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

• Register: EUCTR
• Last refreshed on: 30 June 2014
• Main ID: EUCTR2009-015019-42-LT
• Date of registration: 17/09/2010
• Prospective Registration: Yes
• Primary sponsor: Janssen Biologics B.V.
• Public title: Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
• Scientific title: A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS
• Date of first enrolment: 02/11/2010
• Target sample size: 170
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015019-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: yes Other trial design description: Withdrawal If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Argentina, Austria, Belgium, Brazil, Canada, Finland, Germany, Lithuania, Mexico, Netherlands, Poland, Russian Federation, Serbia, United States

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion criteria

Inclusion criteria:
1. Pediatric subject ages 2 to less than 18 years of age. Age must not be a factor in the ability to continue follow-up with the investigator through the end of the study.
2. Diagnosis must be made per JIA ILAR diagnostic criteria and the onset of disease must have been before the subject’s 16th birthday Active JIA of one of the subtypes described in the protocol.
3. Disease duration of at least 6 months before study entry.
4. Must have = 5 joints with active arthritis as defined by ACR criteria.
5. Active JIA despite current use of oral, intramuscular or subcutaneous methotrexate.
6. If using corticosteroids; must be on a stable dose of = 10 mg prednisone equivalent or 0.2 mg/kg/day (whichever is less) for = 4 weeks before first administration of study agent. If currently not using corticosteroids, the subject must have not received corticosteroids for at least 4 weeks before the first dose administration.
7. If using NSAIDs, must be on a stable dose for = 2 weeks before the first administration of study agent. If not currently using NSAIDs, the subject must not have taken them for at least 2 weeks before the first administration of study agent.
8. Are considered eligible according to the following TB screening criteria:
a. Have no history of latent or active TB before screening. An exception is made for subjects who have a history of latent TB and documentation of having completed an adequate treatment regimen for latent TB within 3 years prior to the first administration of study agent under this protocol. Adequate treatment for latent TB is defined according to local country guidelines for immunocompromised patients. If no local guidelines for immunocompromised patients exist, US guidelines must be followed. It is the responsibility of the investigator to verify the adequacy of previous anti-TB treatment and provide appropriate documentation.
b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
c. Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB before or simultaneously with the first administration of study agent.
d. Within 6 weeks before the first administration of study agent, have a negative QuantiFERON-TB Gold test result or have a newly identified positive TB screening test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either before or simultaneously with the first administration of study agent.
e. Have a chest radiograph, taken within 3 months before the first administration of study agent and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB.
9. Medically stable on the basis of physical examination, medical history, and vital signs performed at screening.
10. Girls of childbearing potential must be:
a. Incapable of pregnancy,
b. Abstinent, or
c. If sexually active, practicing a highly effective method of birth control.
11. All girls of childbearing potential must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening; and a negative urine pregnancy test at each study visit.
12. Boys must practice abstinence or agree to use a double barrier method of birth control and to not donate sperm during the study and for 6 months af
Exclusion criteria:
1. Have known allergies, hypersensitivity, or intolerance to golimumab or other immunoglobulins or its excipients.
2. Are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6 months after the last study agent administration.
3. Have a past history of macrophage activation syndrome (MAS).
4. Have received an investigational drug or used an investigational medical device within 3 months or 5 half lives, before the planned start of treatment or are currently enrolled in an investigational study.
5. Have initiated DMARDS and/or immunosuppressive therapy within 4 weeks prior to study initiation.
6. Have other inflammatory disease that might confound the evaluation of benefit from golimumab therapy.
7. Are incapacitated, largely or wholly bedridden, or confined to a wheelchair, or have little or no ability for age-appropriate self care.
8. Have been treated with intra-articular, intramuscular or intravenous corticosteroids during the 4 weeks before first study agent administration.
9. Have been treated with any therapeutic agent targeted at reducing IL-12 or IL-23.
10. Have been treated with natalizumab, efalizumab, or therapeutic agents that deplete B or T cells during the 12 months before first study agent administration, or have evidence at screening of persistent depletion of the targeted lymphocyte after receiving any of these agents.
11. Have been treated with alefacept or abatacept within 3 months before first study agent administration.
13. Have been treated with leflunomide within 4 weeks before first study agent administration, or have received leflunomide from 4 to 12 weeks before first study agent administration and have not undergone a drug elimination procedure.
14. Have been treated with cytotoxic agents.
15. Have received or are expected to receive any live viral or bacterial vaccinations from 3 months before first study agent administration and up to 3 months after the last study agent administration.
16. Have a history of latent or active granulomatous infection.
17. Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
18. If applicable, have a chest radiograph within 3 months before the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including TB.
19. Have had a nontuberculous mycobacterial infection or opportunistic infection.
20. Have current side effects related to MTX which would preclude treatment with MTX.
21. Have a history of an infected joint prosthesis or have received antibiotics for a suspected infection of a joint prosthesis unless that prosthesis has been removed or replaced.
22. Have or have had a serious infection, or have been hospitalized or received IV antibiotics for an infection during the 2 months before first study agent administration.
23. Have a history of or ongoing chronic or recurrent infectious disease.
24. Have a known history of infection with HIV.
25. Have a known history of hepatitis C infection.
26. Have a known history of demyelinating diseases such as multiple sclerosis.
27. Have a history of lymphoproliferative disease, including lymphoma, or signs suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location, or clinically significant splenomegaly.
28. Have a known malignancy or have a history of malignancy.
29. Have or have had a substance abuse (drug or alcohol) problem.
30. Are unable o

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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870

Intervention(s)

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
Current Sponsor code: CNTO148
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
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)

Primary end point(s): The primary endpoint is the proportion of patients with American College of Rheumatology (ACR) 30 response at week 16 who will not experience a flare of disease between Week 16 and Week 48.

Main Objective: The primary objective of this study is to assess the clinical efficacy of SC administration of golimumab in pediatric subjects (ages 2 to less than 18 years) with JIA manifested by = 5 joints with active arthritis despite methotrexate (MTX) therapy for = 3 months.

Secondary Objective: The secondary objectives of this study are to evaluate golimumab in pediatric subjects with JIA with respect to:

1. Safety.
2. Physical function.
3. Quality of life.
4. Disease activity status over time.
5. Pharmacokinetics and immunogenicity.
6. Pharmacodynamics.

Timepoint(s) of evaluation of this end point: Week 16 through Week 48

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 16 through Week 48

Secondary end point(s): 1. The proportion of patients with American College of Rheumatology (ACR) 30 response at Week 16 who will also achieve ACR 30 response at Week 48.
2. The proportion of patients with American College of Rheumatology (ACR) 30 response at Week 16 who will have inactive disease at Week 48.
3. The proportion of patients with American College of Rheumatology (ACR) 30 response at Week 16 who will achieve clinical remission while on medication for Juvenile Idiopathic Arthritis (JIA) at Week 48.

Secondary ID(s)

2009-015019-42-DE

CNTO148JIA3001

Source(s) of Monetary Support

Centocor R&D