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Trial record 84 of 2725 for:    Rheumatoid Arthritis

Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00690573
Recruitment Status : Completed
First Posted : June 4, 2008
Results First Posted : April 1, 2011
Last Update Posted : September 10, 2012
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Abbott

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Juvenile Rheumatoid Arthritis
Intervention Biological: Adalimumab
Enrollment 25
Recruitment Details  
Pre-assignment Details Adalimumab dose was determined by baseline body weight (20 mg for subjects weighing < 30 kg, 40 mg for subjects weighing 30 kg or more) through Week 14. After Week 16, dose was based on body weight measured at Week 16 and every 12 weeks. Twenty subjects received concomitant methotrexate therapy during the study.
Arm/Group Title Adalimumab
Hide Arm/Group Description Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
Period Title: Overall Study
Started 25
Completed 16
Not Completed 9
Reason Not Completed
Lack of Efficacy             8
Withdrawal by Subject             1
Arm/Group Title Adalimumab
Hide Arm/Group Description Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
25
 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 25 participants
13.0  (3.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
20
  80.0%
Male
5
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 25 participants
25
1.Primary Outcome
Title Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16
Hide Description Response defined as at least 30% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 30% worsening in not more than 1 JRA criterion, compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was conducted using the full analysis set (FAS) population, which was defined as all subjects who received at least one dose of study drug.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Participants
23
2.Secondary Outcome
Title Number of Subjects Achieving PedACR50 and PedACR70 Responses at Week 16
Hide Description Response defined as at least 50/70% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 50/70% worsening in not more than 1 JRA criterion compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was conducted using the full analysis set (FAS) population, which was defined as all subjects who received at least one dose of study drug. Missing values were treated as non-responders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Participants
Number of Subjects Achieving PedACR50 at Week 16 22
Number of Subjects Achieving PedACR70 at Week 16 15
3.Secondary Outcome
Title Number of Subjects Achieving PedACR 30/50/70 Responses
Hide Description [Not Specified]
Time Frame Week 2, 4, 8, and 24, every 12 weeks from Week 24 to Week 60, and every 24 weeks from Week 72 to the final visit
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was conducted using the full analysis set (FAS) population (all subjects who received at least 1 dose of study drug) as observed. N=25 at Weeks 2, 4, and the Final Visit; N=24 at Weeks 8, 24, and 36; N=23 at Week 48; N=22 at Week 60; N=19 at Weeks 72 and 96; N=11 at Week 120; and N=5 at Week 144.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Participants
Number of subjects achieving PedACR30 at Week 2 15
Number of subjects achieving PedACR30 at Week 4 16
Number of subjects achieving PedACR30 at Week 8 19
Number of subjects achieving PedACR30 at Week 24 21
Number of subjects achieving PedACR30 at Week 36 22
Number of subjects achieving PedACR30 at Week 48 21
Number of subjects achieving PedACR30 at Week 60 20
Number of subjects achieving PedACR30 at Week 72 19
Number of subjects achieving PedACR30 at Week 96 18
Number of subjects achieving PedACR30 at Week 120 11
Number of subjects achieving PedACR30 at Week 144 5
Number of subjects achieving PedACR30- Final Visit 22
Number of subjects achieving PedACR50 at Week 2 7
Number of subjects achieving PedACR50 at Week 4 13
Number of subjects achieving PedACR50 at Week 8 15
Number of subjects achieving PedACR50 at Week 24 19
Number of subjects achieving PedACR50 at Week 36 22
Number of subjects achieving PedACR50 at Week 48 19
Number of subjects achieving PedACR50 at Week 60 20
Number of subjects achieving PedACR50 at Week 72 18
Number of subjects achieving PedACR50 at Week 96 18
Number of subjects achieving PedACR50 at Week 120 11
Number of subjects achieving PedACR50 at Week 144 5
Number of subjects achieving PedACR50- Final Visit 20
Number of subjects achieving PedACR70 at Week 2 1
Number of subjects achieving PedACR70 at Week 4 7
Number of subjects achieving PedACR70 at Week 8 8
Number of subjects achieving PedACR70 at Week 24 15
Number of subjects achieving PedACR70 at Week 36 19
Number of subjects achieving PedACR70 at Week 48 17
Number of subjects achieving PedACR70 at Week 60 16
Number of subjects achieving PedACR70 at Week 72 15
Number of subjects achieving PedACR70 at Week 96 14
Number of subjects achieving PedACR70 at Week 120 11
Number of subjects achieving PedACR70 at Week 144 5
Number of subjects achieving PedACR70- Final Visit 17
4.Secondary Outcome
Title Mean Serum Adalimumab Concentration
Hide Description Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method based on a double-antigen technique. Concentrations are reported as micrograms per milliliter (mcg/mL).
Time Frame Week 2, 4, 8, 16, and 24, and every 12 weeks up to Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
For the 20 mg dose, N = 8 at each timepoint. For the 40 mg dose, N = 17 at Weeks 2 and 4; N = 16 at Weeks 8, 16, and 24; N = 14 at Week 36; N = 15 at Week 48; and N = 14 at Week 60.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mcg/mL
20 mg dose at Week 2 5.24  (1.74)
20 mg dose at Week 4 5.46  (5.18)
20 mg dose at Week 8 6.15  (5.88)
20 mg dose at Week 16 5.73  (5.26)
20 mg dose at Week 24 5.79  (6.51)
20 mg dose at Week 36 7.60  (7.58)
20 mg dose at Week 48 7.97  (6.69)
20 mg dose at Week 60 11.4  (9.87)
40 mg dose at Week 2 5.03  (1.45)
40 mg dose at Week 4 5.63  (2.71)
40 mg dose at Week 8 8.66  (4.41)
40 mg dose at Week 16 10.8  (6.15)
40 mg dose at Week 24 11.9  (6.80)
40 mg dose at Week 36 12.6  (6.44)
40 mg dose at Week 48 13.0  (8.89)
40 mg dose at Week 60 13.1  (6.73)
5.Secondary Outcome
Title Number of Subjects Positive for Anti-adalimumab Antibodies (AAA)
Hide Description Serum samples with adalimumab concentration below 2 mcg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 20 ng/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose.
Time Frame Week 24 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Participants
Number of subjects with AAA by Week 24 4
Number of subjects with AAA by Week 60 6
Time Frame All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adalimumab
Hide Arm/Group Description Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
All-Cause Mortality
Adalimumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab
Affected / at Risk (%)
Total   6/25 (24.00%) 
General disorders   
pyrexia * 1  2/25 (8.00%) 
Infections and infestations   
hepatitis B * 1  1/25 (4.00%) 
herpes zoster * 1  1/25 (4.00%) 
pharyngitis * 1  1/25 (4.00%) 
pneumonia * 1  1/25 (4.00%) 
Metabolism and nutrition disorders   
dehydration * 1  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders   
arthralgia * 1  1/25 (4.00%) 
juvenile arthritis * 1  1/25 (4.00%) 
Nervous system disorders   
amnesia * 1  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders   
pharyngolaryngeal pain * 1  1/25 (4.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adalimumab
Affected / at Risk (%)
Total   25/25 (100.00%) 
Blood and lymphatic system disorders   
iron deficiency anaemia * 1  5/25 (20.00%) 
Eye disorders   
conjunctivitis * 1  2/25 (8.00%) 
conjunctivitis allergic * 1  3/25 (12.00%) 
keratoconjunctivitis sicca * 1  2/25 (8.00%) 
Gastrointestinal disorders   
abdominal pain * 1  3/25 (12.00%) 
abdominal pain upper * 1  2/25 (8.00%) 
constipation * 1  3/25 (12.00%) 
dental caries * 1  3/25 (12.00%) 
diarrhoea * 1  3/25 (12.00%) 
nausea * 1  3/25 (12.00%) 
stomatitis * 1  2/25 (8.00%) 
vomiting * 1  2/25 (8.00%) 
General disorders   
injection site erythema * 1  4/25 (16.00%) 
injection site reaction * 1  2/25 (8.00%) 
malaise * 1  2/25 (8.00%) 
pyrexia * 1  5/25 (20.00%) 
Hepatobiliary disorders   
hepatic function abnormal * 1  2/25 (8.00%) 
Immune system disorders   
seasonal allergy * 1  2/25 (8.00%) 
Infections and infestations   
gastroenteritis * 1  6/25 (24.00%) 
hordeolum * 1  5/25 (20.00%) 
impetigo * 1  3/25 (12.00%) 
influenza * 1  8/25 (32.00%) 
nasopharyngitis * 1  14/25 (56.00%) 
oral herpes * 1  3/25 (12.00%) 
pharyngitis * 1  8/25 (32.00%) 
upper respiratory tract infection * 1  14/25 (56.00%) 
Injury, poisoning and procedural complications   
contusion * 1  2/25 (8.00%) 
hand fracture * 1  2/25 (8.00%) 
joint sprain * 1  4/25 (16.00%) 
Investigations   
antinuclear antibody positive * 1  2/25 (8.00%) 
DNA antibody positive * 1  2/25 (8.00%) 
Musculoskeletal and connective tissue disorders   
arthralgia * 1  2/25 (8.00%) 
juvenile arthritis * 1  3/25 (12.00%) 
myalgia * 1  2/25 (8.00%) 
Nervous system disorders   
headache * 1  3/25 (12.00%) 
Respiratory, thoracic and mediastinal disorders   
cough * 1  3/25 (12.00%) 
pharyngolaryngeal pain * 1  4/25 (16.00%) 
rhinitis allergic * 1  3/25 (12.00%) 
rhinorrhoea * 1  2/25 (8.00%) 
Skin and subcutaneous tissue disorders   
acne * 1  2/25 (8.00%) 
dermatitis atopic * 1  2/25 (8.00%) 
dermatitis bullous * 1  2/25 (8.00%) 
eczema * 1  5/25 (20.00%) 
rash * 1  4/25 (16.00%) 
urticaria * 1  6/25 (24.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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.
Disclosure agreements vary; the Medical Institution shall not disclose any material/information disclosed by Abbott Japan in connection with the Clinical Research or information obtained by conducting the Clinical Research to third parties without Abbott Japan's prior written approval. When Medical Institution intends to publish information obtained by conducting Clinical Research, Institution shall obtain Abbott Japan's prior written approval.
Results Point of Contact
Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00690573     History of Changes
Other Study ID Numbers: M10-240
First Submitted: June 2, 2008
First Posted: June 4, 2008
Results First Submitted: March 4, 2011
Results First Posted: April 1, 2011
Last Update Posted: September 10, 2012