A 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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01230827
First received: October 28, 2010
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.


Condition Intervention Phase
Juvenile Idiopathic Arthritis
Drug: CNTO 148 (Golimumab)
Drug: Placebo
Drug: Methotrexate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Humanized Anti-TNFa Antibody, in Subjects With Active Polyarticular Juvenile Idiopathic Arthritis (JIA) Despite Standard Therapy

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • 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 [ Time Frame: Week 16 through Week 48 ] [ Designated as safety issue: No ]
    This will be calculated as number of patients with response divided by number of patients randomized. Flare of disease is defined as 30% or more improvement in at least 3 and 30% or more worsening in no more than 1 of the 6 of the ACR Ped (pediatric) core set variables. The 6 variables are: physicians global assessment of disease, patient/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate.


Secondary Outcome Measures:
  • Proportion of patients with American College of Rheumatology (ACR) 30 response at Week 16 who will also achieve ACR 30 response at Week 48 [ Time Frame: Week 16 through Week 48 ] [ Designated as safety issue: No ]
    This will be calculated as number of patients with response divided by number of patients randomized. ACR Ped 30 response is defined as 30 percent or more improvement from baseline in at least 3 of the following 6 components: physicians global assessment of disease, patient/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate.

  • Proportion of patients with American College of Rheumatology (ACR) 30 response at Week 16 who will have inactive disease at Week 48 [ Time Frame: Week 16 through Week 48 ] [ Designated as safety issue: No ]
    This will be calculated as number of patients with response divided by number of patients randomized. Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate (less than 20 mm/hour) or C-reactive protein (less than 20 mm/hour); physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.

  • 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 [ Time Frame: Week 16 through Week 48 ] [ Designated as safety issue: No ]
    This will be calculated as number of patients with response divided by number of patients randomized. Clinical remission while on medication for JIA is defined as inactive disease at each visit for a period of 6 months or more while on medication. Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate (less than 20 mm/hour) or C-reactive protein (less than 20 mm/hour); physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.


Enrollment: 173
Study Start Date: December 2010
Estimated Study Completion Date: May 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CNTO 148 (Golimumab)
All patients will receive golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Patients who have a clinical response at Week 16 and who are randomly allocated to golimumab, will receive 30 mg per square meter every 4 weeks through Week 48. Patients will continue to receive golimumab 30 mg per square meter after Week 48 in a long-term extension until Week 248. All patients will receive their fixed dose of commercial methotrexate throughout the study duration.
Drug: CNTO 148 (Golimumab)
Patients will receive subcutaneous (SC) (under the skin) injection of golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 248.
Drug: Methotrexate
All patients will receive their fixed dose of commercial methotrexate (10 to 30 mg per square meter) weekly throughout the study duration.
Placebo Comparator: Placebo
All patients will receive golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Patients who have a clinical response to golimumab at Week 16 and are randomly allocated to placebo, will receive placebo every 4 weeks through Week 48. However, patients receiving placebo and who will have lack/loss of clinical response will be eligible to receive golimumab 30 mg per square meter every 4 weeks through Week 48. At Week 48, patients do not have a clinical response will begin to receive golimumab 30 mg per square meter in a long-term extension until Week 248 and patients who have a clinical response will be discontinued from the study. All patients will receive their fixed dose of commercial methotrexate throughout the study duration.
Drug: Placebo
Patients who have a clinical response to golimumab at Week 16 and are randomly allocated to placebo, will receive SC injection of placebo every 4 weeks from Week 16 through Week 48.
Drug: Methotrexate
All patients will receive their fixed dose of commercial methotrexate (10 to 30 mg per square meter) weekly throughout the study duration.

Detailed Description:

Approximately 170 juvenile patients will take part in the study worldwide. All patients will receive 30mg/m2 (milligrams per meter squared, up to 50 mg per dose) of golimumab subcutaneously (injection under the skin) every 4 weeks from Week 0 through Week 12. At Week 16, patients who have shown at least a 30 percent improvement in their signs and symptoms from when they started the study will be randomized to receive either placebo (sham medicine injection) or 30 mg/m2 of golimumab injections every 4 weeks from week 16 through week 48. If a patient gets markedly worse and is receiving placebo injections, they will be restarted on golimumab at the next scheduled visit and will continue on golimumab. Patients can leave the study at any time without question. Between the Week 48 analyses timepoint to Week 144, which is subsequently amended to Week 248, all patients will receive golimumab 30mg/meter squared, unless, by measurements, they have been nearly cured (clinical remission) by being on placebo, whereby they will be discontinued from the study. Patients may have a change in background treatment after Week 48 based on therapeutic effect. Patients will continue active treatment after Week 48 in a long-term extension until Week 144, which is subsequently amended to Week 248. All patients will receive their fixed dose of commercial methotrexate throughout the study duration. Safety will be monitored up to 152 week, which is subsequently amended to 256 weeks including drawing blood and looking at laboratory tests, vital signs (eg, blood pressure), and the frequency and type of adverse events (side effects).

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis must have been before the patient's 16th birthday
  • Disease duration of at least 6 months before study entry
  • Must have 5 or more joints with active arthritis
  • Must be taking a stable dose of methotrexate 10-30 mg/meter squared (patients with body surface area [BSA] 1.67 square meter or more must be taking a minimum of 15 mg/week of methotrexate)
  • May take a stable dose of prednisone less than 10 mg/day 4 weeks prior to entry or may take a stable dose of NSAIDS (non-steroidal anti-inflammatory drugs) 2 weeks prior to entry
  • Must have qualifying laboratory values at the first visit.

Exclusion Criteria:

  • Have known allergies, hypersensitivity, or intolerance to golimumab or similar therapeutics
  • Are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6 months after the last study agent administration
  • Have initiated DMARDS and/or immunosuppressive therapy within 4 weeks prior to study initiation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230827

  Hide Study Locations
Locations
United States, California
Los Angeles, California, United States
San Francisco, California, United States
United States, Georgia
Augusta, Georgia, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Ohio
Cincinatti, Ohio, United States
United States, Oregon
Portland, Oregon, United States
Austria
Bregenz, Austria
Wien, Austria
Belgium
Brussels, Belgium
Gent, Belgium
Leuven, Belgium
Brazil
Botucatu, Brazil
Curitiba, Brazil
Ribeirão Preto, Brazil
Rio De Janeiro, Brazil
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Toronto, Ontario, Canada
Finland
Helsinki, Finland
Oulu, Finland
Germany
Bad Bramstedt, Germany
Berlin, Germany
Bremen, Germany
Hamburg, Germany
Sankt Augustin, Germany
Lithuania
Vilnius, Lithuania
Mexico
Ciudad De Mexico, Mexico
Monterrey, Mexico
San Luis Potosi, Mexico
Netherlands
Utrecht, Netherlands
Poland
Krakow, Poland
Lodz, Poland
Russian Federation
Moscow, Russian Federation
Saint-Petersburg, Russian Federation
Samara, Russian Federation
Sponsors and Collaborators
Janssen Research & Development, LLC
Schering-Plough
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01230827     History of Changes
Obsolete Identifiers: NCT01777399
Other Study ID Numbers: CR017089, CNTO148JIA3001, 2009-015019-42
Study First Received: October 28, 2010
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Juvenile Idiopathic Arthritis
golimumab
juvenile arthritis
GO KIDS
anti TNF alpha medications
juvenile psoriatic arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014