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Trial record 16 of 137 for:    "Connective Tissue Disease" | "Abatacept"

Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan

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ClinicalTrials.gov Identifier: NCT01835470
Recruitment Status : Completed
First Posted : April 19, 2013
Results First Posted : January 11, 2017
Last Update Posted : September 25, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Juvenile Idiopathic Arthritis
Intervention Drug: Abatacept
Enrollment 23
Recruitment Details 23 participants were enrolled and 20 participants were treated. Reason for non-treatment was that 3 participants no longer met study criteria.
Pre-assignment Details  
Arm/Group Title Abatacept
Hide Arm/Group Description Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Period Title: Short Term Treatment Period (to Week 16)
Started 20
Completed 20
Not Completed 0
Period Title: Long Term Treatment Period
Started 20
Completed 18 [1]
Not Completed 2
Reason Not Completed
Subject Request to Discontinue             1
Lack of Efficacy             1
[1]
Completed=Still on Treatment
Arm/Group Title Abatacept
Hide Arm/Group Description Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
All Treated Participants: All participants who received at least one dose of study medication
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
20
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
10.2  (3.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
15
  75.0%
Male
5
  25.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Japanese Number Analyzed 20 participants
20
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 20 participants
20
1.Primary Outcome
Title Percentage of Participants Experiencing a American College of Rheumatology (ACR) Pediatric 30 Response at Week 16
Hide Description American College of Rheumatology (ACR) pediatric (PED) 30 response was defined as '≥30% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. JIA core set variables defined as the number of active joints, number of joints with Limit of Motion (LOM), physician's global assessment of disease severity, patient global assessment of overall well being, parent assessment of physical function, and acute phase reactant value. A non-responder imputation was applied.
Time Frame Week 16 (Day 113)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants: All participants who received at least one dose of study medication
Arm/Group Title Abatacept
Hide Arm/Group Description:
Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
90.0
(68.3 to 98.8)
2.Secondary Outcome
Title Percentage of Participants Experiencing a American College of Rheumatology Pediatric 50, 70, 90 Response or Inactive Disease at Week 16
Hide Description ACR PED 50 response is defined as '≥50% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 70 response is defined as '≥70% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 90 response is defined as '≥90% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. Inactive disease status is defined as no active joints, physician’s global assessment of disease severity equal or less than 10mm and C-reactive protein (CRP) within normal limits (0.3 mg/dL). A non-responder imputation is applied. mm=millimeter; mg/dL=milligrams/deciliter
Time Frame Week 16 (Day 113)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants: All participants who received at least one dose of study medication
Arm/Group Title Abatacept
Hide Arm/Group Description:
Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
ACR PED 50
75.0
(50.9 to 91.3)
ACR PED 70
70.0
(45.7 to 88.1)
ACR PED 90
35.0
(15.4 to 59.2)
Inactive Disease
25.0
(8.7 to 49.1)
3.Secondary Outcome
Title Median Percentage of Improvement From Baseline in Physical Function as Assessed by the Childhood Health Assessment Questionnaire (CHAQ) Disability Index at Week 16
Hide Description Physical function was evaluated using the disability section of the Childhood Health Assessment Questionnaire (CHAQ). The questionnaire was derived from the adult HAQ. The disability section assessed physical functions in 8 domains: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities. The questions were evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 =unable to do. Higher scores indicate greater dysfunction. A disability index was calculated as the mean of the 8 functional scales. The percentage of Improvement from baseline was calculated using the following equation: (Baseline value - Post-baseline value) / Baseline value x 100.
Time Frame Week 16 (Day 113)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants: All participants who received at least one dose of study medication
Arm/Group Title Abatacept
Hide Arm/Group Description:
Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Overall Number of Participants Analyzed 20
Median (Inter-Quartile Range)
Unit of Measure: percentage of improvement from baseline
43.18
(0.00 to 100.00)
4.Secondary Outcome
Title Number of Participants With Death, Serious Adverse Events (SAEs), Drug-Related SAEs, Discontinuation Due to Drug-Related SAEs, Drug-Related Adverse Events (AEs), and Discontinuation Due to Drug-Related AEs During the Short Term Period
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. SAEs also include hospitalizations for elective surgical procedures. Drug-related=related or missing relationship to study drug. Data includes all events from the date of the first dose of the study drug up to 56 days post the last dose of the study drug in the short-term period or start of the long-term period, whichever occurred first.
Time Frame Day 1 up to 56 days post Week 16 (Day 113); approximately 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants: All participants who received at least one dose of study medication
Arm/Group Title Abatacept
Hide Arm/Group Description:
Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
Death 0
SAEs 2
Drug-Related SAEs 1
Discontinuation Due to Drug-Related SAEs 0
Drug-Related AEs 5
Discontinuation Due to Drug-Related AEs 0
5.Secondary Outcome
Title Maximum Observed Concentration (Cmax) of Abatacept During the Short Term Period
Hide Description Cmax was obtained from the serum concentration versus time data after intravenous administration of abatacept. Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter
Time Frame 9 time points up to Week 16 (Day 113)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Analysis Population: All participants who received at least one dose of study medication and who had at least one adequate PK result reported after start of study medication. The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).
Arm/Group Title Abatacept
Hide Arm/Group Description:
Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Overall Number of Participants Analyzed 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
Day 57
163.13
(26.22%)
Day 85
172.43
(23.15%)
Day 113
167.85
(18.42%)
6.Secondary Outcome
Title Trough Observed Concentration (Ctrough) of Abatacept During the Short Term Period
Hide Description Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter
Time Frame 9 time points up to Week 16 (Day 113)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Analysis Population: All participants who received at least one dose of study medication and who had at least one adequate PK result reported after start of study medication. The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).
Arm/Group Title Abatacept
Hide Arm/Group Description:
Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Overall Number of Participants Analyzed 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
Day 15 (n=18)
25.50
(27.61%)
Day 29 (n=17)
38.64
(29.08%)
Day 57 (n=20)
17.24
(36.63%)
Day 85 (n=18)
16.79
(40.01%)
Day 113 (n=19)
15.56
(36.61%)
7.Secondary Outcome
Title Number of Participants With Positive Immunogenicity During the Short Term Period
Hide Description A positive immunogenicity response for 'Cytotoxic T-lymphocyte antigen (CTLA4), Immunoglobulin (Ig)', 'Ig and/or Junction Region', respectively = (1) missing baseline immunogenicity measurement and positive analytical laboratory reported immunogenicity response post-baseline (2) negative baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline (3) positive baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline with titer value strictly greater than the baseline titer value. Assessment based on assay cutpoint value. Serum samples were collected prior to study medication at Week 0 (Day 1), Week 8 (Day 57), and Week 16 (Day 113) in the short term period. Participants who early discontinued from the study or complete and did not switch to commercial abatacept had a serum sample collected on final visit or early termination visit, 28, 84 and 168 days after the last dose.
Time Frame Day 1 up to Week 16 (Day 113)
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity analysis population: All participants who received at least one dose of study medication and who had at least one immunogenicity result reported after start of study medication
Arm/Group Title Abatacept
Hide Arm/Group Description:
Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
0
Time Frame Day 1 up to 56 days post Week 52; approximately 1 year for the last participant
Adverse Event Reporting Description Study Start: August 2013; Study Reached PE Completion: November 2015. Study on-going.
 
Arm/Group Title Abatacept
Hide Arm/Group Description Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study.
All-Cause Mortality
Abatacept
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abatacept
Affected / at Risk (%)
Total   4/20 (20.00%) 
Infections and infestations   
Gastroenteritis  1  1/20 (5.00%) 
Varicella  1  1/20 (5.00%) 
Viral tonsillitis  1  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders   
Juvenile idiopathic arthritis  1  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abatacept
Affected / at Risk (%)
Total   20/20 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  1/20 (5.00%) 
Eye disorders   
Conjunctivitis allergic  1  1/20 (5.00%) 
Dry eye  1  2/20 (10.00%) 
Scleritis  1  1/20 (5.00%) 
Gastrointestinal disorders   
Diarrhoea  1  2/20 (10.00%) 
Toothache  1  1/20 (5.00%) 
Haemorrhoids  1  1/20 (5.00%) 
Stomatitis  1  5/20 (25.00%) 
Abdominal pain  1  1/20 (5.00%) 
Dental caries  1  1/20 (5.00%) 
Nausea  1  4/20 (20.00%) 
Vomiting  1  1/20 (5.00%) 
Abdominal pain upper  1  2/20 (10.00%) 
Enterocolitis  1  1/20 (5.00%) 
Aphthous ulcer  1  2/20 (10.00%) 
Constipation  1  2/20 (10.00%) 
General disorders   
Pyrexia  1  3/20 (15.00%) 
Injection site swelling  1  1/20 (5.00%) 
Non-cardiac chest pain  1  1/20 (5.00%) 
Hypothermia  1  1/20 (5.00%) 
Immune system disorders   
Allergy to arthropod sting  1  1/20 (5.00%) 
Seasonal allergy  1  4/20 (20.00%) 
Infections and infestations   
Pharyngitis  1  10/20 (50.00%) 
Otitis externa  1  1/20 (5.00%) 
Otitis media acute  1  1/20 (5.00%) 
Rhinitis  1  2/20 (10.00%) 
Upper respiratory tract infection  1  3/20 (15.00%) 
Cystitis  1  1/20 (5.00%) 
Enteritis infectious  1  1/20 (5.00%) 
Oral candidiasis  1  1/20 (5.00%) 
Tonsillitis  1  1/20 (5.00%) 
Viral pharyngitis  1  3/20 (15.00%) 
Viral rash  1  1/20 (5.00%) 
Angular cheilitis  1  2/20 (10.00%) 
Bronchitis  1  4/20 (20.00%) 
Gastroenteritis  1  4/20 (20.00%) 
Varicella  1  1/20 (5.00%) 
Influenza  1  7/20 (35.00%) 
Nasopharyngitis  1  14/20 (70.00%) 
Oral herpes  1  1/20 (5.00%) 
Tinea infection  1  1/20 (5.00%) 
Conjunctivitis  1  1/20 (5.00%) 
Enterocolitis viral  1  1/20 (5.00%) 
Gastroenteritis viral  1  1/20 (5.00%) 
Herpes simplex  1  1/20 (5.00%) 
Hordeolum  1  1/20 (5.00%) 
Paronychia  1  1/20 (5.00%) 
Injury, poisoning and procedural complications   
Arthropod sting  1  1/20 (5.00%) 
Frostbite  1  1/20 (5.00%) 
Limb injury  1  1/20 (5.00%) 
Radius fracture  1  1/20 (5.00%) 
Contusion  1  4/20 (20.00%) 
Joint dislocation  1  1/20 (5.00%) 
Ligament sprain  1  3/20 (15.00%) 
Excoriation  1  1/20 (5.00%) 
Wound  1  2/20 (10.00%) 
Arthropod bite  1  1/20 (5.00%) 
Eye contusion  1  1/20 (5.00%) 
Investigations   
Alanine aminotransferase increased  1  1/20 (5.00%) 
Bone density decreased  1  1/20 (5.00%) 
Metabolism and nutrition disorders   
Hypoglycaemia  1  1/20 (5.00%) 
Obesity  1  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/20 (10.00%) 
Tendonitis  1  1/20 (5.00%) 
Myalgia  1  2/20 (10.00%) 
Arthritis  1  1/20 (5.00%) 
Back pain  1  1/20 (5.00%) 
Joint swelling  1  1/20 (5.00%) 
Neck pain  1  1/20 (5.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Skin papilloma  1  2/20 (10.00%) 
Nervous system disorders   
Headache  1  5/20 (25.00%) 
Restless legs syndrome  1  1/20 (5.00%) 
Reproductive system and breast disorders   
Balanoposthitis  1  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory tract inflammation  1  5/20 (25.00%) 
Epistaxis  1  3/20 (15.00%) 
Rhinorrhoea  1  1/20 (5.00%) 
Cough  1  1/20 (5.00%) 
Rhinitis allergic  1  1/20 (5.00%) 
Skin and subcutaneous tissue disorders   
Eczema  1  2/20 (10.00%) 
Acne  1  3/20 (15.00%) 
Asteatosis  1  1/20 (5.00%) 
Rash  1  2/20 (10.00%) 
Dermatitis  1  1/20 (5.00%) 
Purpura  1  1/20 (5.00%) 
Skin ulcer  1  1/20 (5.00%) 
Ingrowing nail  1  1/20 (5.00%) 
Alopecia  1  2/20 (10.00%) 
Dry skin  1  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01835470     History of Changes
Other Study ID Numbers: IM101-365
First Submitted: April 17, 2013
First Posted: April 19, 2013
Results First Submitted: November 15, 2016
Results First Posted: January 11, 2017
Last Update Posted: September 25, 2018