Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy (GO-VIVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277444
Recruitment Status : Active, not recruiting
First Posted : October 29, 2014
Results First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Arthritis, Juvenile
Interventions Drug: Golimumab
Drug: Methotrexate
Enrollment 130
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Golimumab
Hide Arm/Group Description Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square (m^2), or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted.
Period Title: Overall Study
Started 130
Treated 127
Completed 0
Not Completed 130
Reason Not Completed
Adverse Event             10
Withdrawal by Subject             3
Other             1
Enrolled and not Treated             3
Ongoing             113
Arm/Group Title Golimumab
Hide Arm/Group Description Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square (m^2), or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted.
Overall Number of Baseline Participants 127
Hide Baseline Analysis Population Description
Full analysis set included all participants who received at least 1 dose of study agent.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 127 participants
11.6  (3.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants
Female
93
  73.2%
Male
34
  26.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants
Hispanic or Latino
63
  49.6%
Not Hispanic or Latino
62
  48.8%
Unknown or Not Reported
2
   1.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants
American Indian or Alaska Native
4
   3.1%
Asian
1
   0.8%
Black or African American
5
   3.9%
More than one race
4
   3.1%
Other
28
  22.0%
White
85
  66.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants
ARGENTINA
18
  14.2%
BRAZIL
16
  12.6%
CANADA
7
   5.5%
CHILE
7
   5.5%
ISRAEL
2
   1.6%
MEXICO
25
  19.7%
RUSSIAN FEDERATION
14
  11.0%
SOUTH AFRICA
15
  11.8%
UNITED STATES
23
  18.1%
1.Primary Outcome
Title Serum Trough Concentration (C-trough) of Golimumab
Hide Description Serum golimumab trough concentration at Week 28 was reported.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Arm/Group Title Golimumab
Hide Arm/Group Description:
Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square (m^2), or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted.
Overall Number of Participants Analyzed 87
Mean (Standard Deviation)
Unit of Measure: micrograms per milliliter (mcg/mL)
0.50  (0.427)
2.Primary Outcome
Title Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28
Hide Description AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis.
Arm/Group Title Golimumab
Hide Arm/Group Description:
Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square (m^2), or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted.
Overall Number of Participants Analyzed 127
Median (Full Range)
Unit of Measure: micrograms*day/milliliter (mcg*day/mL)
399
(387 to 424)
3.Secondary Outcome
Title Serum Trough Concentration (C-trough) at Week 52
Hide Description Serum golimumab trough concentration at Week 52 was reported.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Arm/Group Title Golimumab
Hide Arm/Group Description:
Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square (m^2), or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted.
Overall Number of Participants Analyzed 95
Mean (Standard Deviation)
Unit of Measure: mcg/mL
0.52  (0.475)
4.Secondary Outcome
Title Baysesian Area Under Curve at Steady State (AUCss) at Week 52
Hide Description AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis.
Arm/Group Title Golimumab
Hide Arm/Group Description:
Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square (m^2), or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted.
Overall Number of Participants Analyzed 127
Median (Full Range)
Unit of Measure: mcg*day/mL
421
(402 to 446)
Time Frame Up to Week 52
Adverse Event Reporting Description Safety evaluable analysis set included all participants who received at least 1 dose of study agent.
 
Arm/Group Title Golimumab
Hide Arm/Group Description Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square (m^2), or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted.
All-Cause Mortality
Golimumab
Affected / at Risk (%)
Total   0/127 (0.00%) 
Hide Serious Adverse Events
Golimumab
Affected / at Risk (%)
Total   9/127 (7.09%) 
Infections and infestations   
Cellulitis * 1  1/127 (0.79%) 
Herpes Zoster Disseminated * 1  1/127 (0.79%) 
Infective Exacerbation of Bronchiectasis * 1  1/127 (0.79%) 
Pneumonia * 1  1/127 (0.79%) 
Pneumonia Streptococcal * 1  1/127 (0.79%) 
Sepsis * 1  1/127 (0.79%) 
Varicella * 1  1/127 (0.79%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Mycosis Fungoides * 1  1/127 (0.79%) 
Psychiatric disorders   
Suicidal Ideation * 1  1/127 (0.79%) 
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion * 1  1/127 (0.79%) 
1
Term from vocabulary, MedDRA Version 21.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Golimumab
Affected / at Risk (%)
Total   71/127 (55.91%) 
Gastrointestinal disorders   
Abdominal Pain * 1  8/127 (6.30%) 
Nausea * 1  11/127 (8.66%) 
Vomiting * 1  10/127 (7.87%) 
Infections and infestations   
Nasopharyngitis * 1  23/127 (18.11%) 
Upper Respiratory Tract Infection * 1  27/127 (21.26%) 
Investigations   
Alanine Aminotransferase Increased * 1  7/127 (5.51%) 
Musculoskeletal and connective tissue disorders   
Juvenile Idiopathic Arthritis * 1  14/127 (11.02%) 
Nervous system disorders   
Headache * 1  14/127 (11.02%) 
1
Term from vocabulary, MedDRA Version 21.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director Clinical Development
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02277444    
Other Study ID Numbers: CR105178
CNTO148JIA3003 ( Other Identifier: Janssen Research & Development, LLC )
2015-004804-47 ( EudraCT Number )
First Submitted: October 27, 2014
First Posted: October 29, 2014
Results First Submitted: October 27, 2020
Results First Posted: November 18, 2020
Last Update Posted: November 18, 2020