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)

• ClinicalTrials.gov Identifier: NCT01230827
• Recruitment Status: Terminated
• First Posted: October 29, 2010
• Results First Posted: September 29, 2014
• Last Update Posted: April 4, 2016
• Sponsor: Janssen Research & Development, LLC
• Collaborator: Schering-Plough
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Juvenile Idiopathic Arthritis	Drug: CNTO 148 (Golimumab); Drug: Placebo; Drug: Methotrexate	Phase 3

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 173 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, 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
• Study Start Date: December 2010
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: May 2014

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48 [ Time Frame: Week 16 through Week 48 ]
   Percentage of participants with American College of Rheumatology (ACR) Ped 30 responders at Week 16 who did not experience a flare of disease between Week 16 and Week 48 calculated as number of participants with response and who did not experience flare divided by number of participants randomized. Flare of disease was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/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 :

1. Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48 [ Time Frame: Week 16 through Week 48 ]
   Percentage of participants with ACR 30 response at Week 48 was calculated as number of participants with ACR 30 response at Week 48 divided by number of participants randomized. ACR Ped 30 response was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/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.
2. Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48 [ Time Frame: Week 16 through Week 48 ]
   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 or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.
3. Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48 [ Time Frame: Week 16 through Week 48 ]
   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 or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Brunner HI, Ruperto N, Tzaribachev N, Horneff G, Chasnyk VG, Panaviene V, Abud-Mendoza C, Reiff A, Alexeeva E, Rubio-Pérez N, Keltsev V, Kingsbury DJ, Del Rocio Maldonado Velázquez M, Nikishina I, Silverman ED, Joos R, Smolewska E, Bandeira M, Minden K, van Royen-Kerkhof A, Emminger W, Foeldvari I, Lauwerys BR, Sztajnbok F, Gilmer KE, Xu Z, Leu JH, Kim L, Lamberth SL, Loza MJ, Lovell DJ, Martini A; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial. Ann Rheum Dis. 2018 Jan;77(1):21-29. doi: 10.1136/annrheumdis-2016-210456. Epub 2017 May 15.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT01230827
• Obsolete Identifiers: NCT01777399
• Other Study ID Numbers: CR017089; CNTO148JIA3001 ( Other Identifier: Janssen Research & Development, LLC ); 2009-015019-42 ( EudraCT Number )
• First Posted: October 29, 2010
• Results First Posted: September 29, 2014
• Last Update Posted: April 4, 2016
• Last Verified: March 2016

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; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Golimumab; Methotrexate; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents; Physiological Effects of Drugs; 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; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents