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Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

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ClinicalTrials.gov Identifier: NCT00791999
Recruitment Status : Completed
First Posted : November 17, 2008
Results First Posted : August 6, 2012
Last Update Posted : August 10, 2012
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: CDP870 400mg
Drug: CDP870 200mg
Drug: CDP870 100mg
Drug: Placebo of CDP870
Enrollment 316
Recruitment Details Subjects were recruited in Japan between 2008 and 2010.
Pre-assignment Details Participant flow results are based on the safety set.
Arm/Group Title CDP870 100mg CDP870 200mg CDP870 400mg Placebo
Hide Arm/Group Description 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks 400mg CDP870 given every 2 weeks Placebo given every 2 weeks
Period Title: Overall Study
Started 72 82 85 77
Completed 51 66 65 25
Not Completed 21 16 20 52
Reason Not Completed
Protocol planed withdrawal             14             11             11             45
Withdrawal by Subject             0             1             0             2
Protocol Violation             3             0             1             0
Adverse Event             3             3             7             3
Lack of Efficacy             0             1             0             2
Reason other than those above             1             0             1             0
Arm/Group Title CDP870 100mg CDP870 200mg CDP870 400mg Placebo Total
Hide Arm/Group Description 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks 400mg CDP870 given every 2 weeks Placebo given every 2 weeks Total of all reporting groups
Overall Number of Baseline Participants 72 82 85 77 316
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 82 participants 85 participants 77 participants 316 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
61
  84.7%
77
  93.9%
66
  77.6%
68
  88.3%
272
  86.1%
>=65 years
11
  15.3%
5
   6.1%
19
  22.4%
9
  11.7%
44
  13.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 82 participants 85 participants 77 participants 316 participants
54.3  (10.6) 50.6  (11.4) 55.4  (10.3) 51.9  (11.1) 53.0  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 82 participants 85 participants 77 participants 316 participants
Female
58
  80.6%
69
  84.1%
69
  81.2%
66
  85.7%
262
  82.9%
Male
14
  19.4%
13
  15.9%
16
  18.8%
11
  14.3%
54
  17.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 72 participants 82 participants 85 participants 77 participants 316 participants
72 82 85 77 316
1.Primary Outcome
Title American College of Rheumatology 20% (ACR20) Response at Week 12
Hide Description ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All 316 subjects (72 CDP 100 mg, 82 CDP 200 mg, 85 CDP 100 mg, 77 Placebo) included in the Full Analysis Set (FAS) are included in this analysis
Arm/Group Title CDP870 100mg CDP870 200mg CDP870 400mg Placebo
Hide Arm/Group Description:
200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
400mg CDP870 given every 2 weeks
Placebo given every 2 weeks
Overall Number of Participants Analyzed 72 82 85 77
Measure Type: Number
Unit of Measure: percentage of participants
62.5 76.8 77.6 28.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CDP870 100mg, CDP870 200mg, CDP870 400mg
Comments For ACR20 responder rate at Week 12, treatment comparisons versus placebo for the two CDP870 dose groups, the CDP870 200 mg group the CDP870 400 mg, were performed. The ACR20 responder rate in the CDP870 100 mg group was used for the secondary analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.025
Comments Wald p-values(vs. placebo) for the comparison of the treatment groups have been calculated using logistic regression with factors for treatment.
Method Regression, Logistic
Comments [Not Specified]
2.Secondary Outcome
Title American College of Rheumatology 20% (ACR20) Response at Week 24
Hide Description ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All 316 subjects (72 CDP 100 mg, 82 CDP 200 mg, 85 CDP 100 mg, 77 Placebo) included in the Full Analysis Set (FAS) are included in this analysis
Arm/Group Title CDP870 100mg CDP870 200mg CDP870 400mg Placebo
Hide Arm/Group Description:
200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
400mg CDP870 given every 2 weeks
Placebo given every 2 weeks
Overall Number of Participants Analyzed 72 82 85 77
Measure Type: Number
Unit of Measure: percentage of participants
61.1 73.2 71.8 24.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CDP870 100mg, CDP870 200mg, CDP870 400mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Wald p-values(vs. placebo) for the comparison of the treatment groups have been calculated using logistic regression with factors for treatment.
Method Regression, Logistic
Comments [Not Specified]
Time Frame 24-week double blind phase, from Baseline to Week 24
Adverse Event Reporting Description Of the 316 subjects in the Full Analysis Set (FAS), 316 are included in the adverse event reporting based upon the Safety Set (SS) population. The Safety Set includes all subjects randomized who received at least 1 dosing.
 
Arm/Group Title CDP870 100mg CDP870 200mg CDP870 400mg Placebo
Hide Arm/Group Description 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks 400mg CDP870 given every 2 weeks Placebo given every 2 weeks
All-Cause Mortality
CDP870 100mg CDP870 200mg CDP870 400mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
CDP870 100mg CDP870 200mg CDP870 400mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/72 (4.17%)      4/82 (4.88%)      5/85 (5.88%)      1/77 (1.30%)    
Blood and lymphatic system disorders         
Bone marrow failure  1  1/72 (1.39%)  1 0/82 (0.00%)  0 0/85 (0.00%)  0 0/77 (0.00%)  0
Cardiac disorders         
Acute myocardial infarction  1  0/72 (0.00%)  0 0/82 (0.00%)  0 1/85 (1.18%)  1 0/77 (0.00%)  0
Eye disorders         
Corneal perforation  1  0/72 (0.00%)  0 0/82 (0.00%)  0 1/85 (1.18%)  2 0/77 (0.00%)  0
Gastrointestinal disorders         
Anal fistula  1  0/72 (0.00%)  0 0/82 (0.00%)  0 0/85 (0.00%)  0 1/77 (1.30%)  1
Infections and infestations         
Bronchitis  1  0/72 (0.00%)  0 1/82 (1.22%)  1 0/85 (0.00%)  0 0/77 (0.00%)  0
Pyelonephritis  1  0/72 (0.00%)  0 1/82 (1.22%)  1 0/85 (0.00%)  0 0/77 (0.00%)  0
Pyomyositis  1  0/72 (0.00%)  0 1/82 (1.22%)  1 0/85 (0.00%)  0 0/77 (0.00%)  0
Subcutaneous abscess  1  0/72 (0.00%)  0 1/82 (1.22%)  1 0/85 (0.00%)  0 0/77 (0.00%)  0
Urosepsis  1  0/72 (0.00%)  0 1/82 (1.22%)  1 0/85 (0.00%)  0 0/77 (0.00%)  0
Enterocolitis viral  1  1/72 (1.39%)  1 0/82 (0.00%)  0 0/85 (0.00%)  0 0/77 (0.00%)  0
Injury, poisoning and procedural complications         
Spinal compression fracture  1  1/72 (1.39%)  1 0/82 (0.00%)  0 0/85 (0.00%)  0 0/77 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Rheumatoid arthritis  1  0/72 (0.00%)  0 1/82 (1.22%)  1 1/85 (1.18%)  1 0/77 (0.00%)  0
Nervous system disorders         
Meningitis noninfective  1  0/72 (0.00%)  0 0/82 (0.00%)  0 1/85 (1.18%)  1 0/77 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Interstitial lung disease  1  0/72 (0.00%)  0 0/82 (0.00%)  0 2/85 (2.35%)  2 0/77 (0.00%)  0
Organising pneumonia  1  1/72 (1.39%)  1 0/82 (0.00%)  0 0/85 (0.00%)  0 0/77 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
CDP870 100mg CDP870 200mg CDP870 400mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/72 (54.17%)      44/82 (53.66%)      41/85 (48.24%)      30/77 (38.96%)    
Eye disorders         
Conjunctivitis allergic  1  4/72 (5.56%)  4 2/82 (2.44%)  2 1/85 (1.18%)  1 1/77 (1.30%)  1
Gastrointestinal disorders         
Periodontitis  1  1/72 (1.39%)  1 2/82 (2.44%)  3 4/85 (4.71%)  4 2/77 (2.60%)  2
General disorders         
Administration site reaction  1  3/72 (4.17%)  7 1/82 (1.22%)  1 2/85 (2.35%)  3 0/77 (0.00%)  0
Hepatobiliary disorders         
Hepatic function abnormal  1  8/72 (11.11%)  8 3/82 (3.66%)  3 5/85 (5.88%)  5 4/77 (5.19%)  4
Liver disorder  1  0/72 (0.00%)  0 3/82 (3.66%)  3 2/85 (2.35%)  2 0/77 (0.00%)  0
Infections and infestations         
Bronchitis  1  0/72 (0.00%)  0 1/82 (1.22%)  1 4/85 (4.71%)  5 1/77 (1.30%)  1
Influenza  1  0/72 (0.00%)  0 3/82 (3.66%)  3 1/85 (1.18%)  1 0/77 (0.00%)  0
Nasopharyngitis  1  8/72 (11.11%)  8 11/82 (13.41%)  15 13/85 (15.29%)  18 9/77 (11.69%)  10
Pharyngitis  1  5/72 (6.94%)  5 5/82 (6.10%)  5 2/85 (2.35%)  2 3/77 (3.90%)  3
Upper respiratory tract infection  1  5/72 (6.94%)  5 2/82 (2.44%)  2 3/85 (3.53%)  4 3/77 (3.90%)  3
Investigations         
Cell marker increased  1  1/72 (1.39%)  1 2/82 (2.44%)  2 4/85 (4.71%)  4 0/77 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Rheumatoid arthritis  1  3/72 (4.17%)  3 3/82 (3.66%)  3 2/85 (2.35%)  2 9/77 (11.69%)  9
Nervous system disorders         
Headache  1  2/72 (2.78%)  2 0/82 (0.00%)  0 3/85 (3.53%)  3 0/77 (0.00%)  0
Psychiatric disorders         
Insomnia  1  3/72 (4.17%)  3 1/82 (1.22%)  1 0/85 (0.00%)  0 0/77 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Upper respiratory tract inflammation  1  1/72 (1.39%)  1 2/82 (2.44%)  2 3/85 (3.53%)  3 1/77 (1.30%)  1
Skin and subcutaneous tissue disorders         
Dermatitis allergic  1  1/72 (1.39%)  1 3/82 (3.66%)  3 0/85 (0.00%)  0 0/77 (0.00%)  0
Eczema  1  4/72 (5.56%)  4 3/82 (3.66%)  3 4/85 (4.71%)  4 2/77 (2.60%)  2
Hyperkeratosis  1  3/72 (4.17%)  3 0/82 (0.00%)  0 0/85 (0.00%)  0 1/77 (1.30%)  1
Rash  1  2/72 (2.78%)  3 4/82 (4.88%)  4 2/85 (2.35%)  2 1/77 (1.30%)  1
Vascular disorders         
Hypertension  1  3/72 (4.17%)  3 3/82 (3.66%)  3 2/85 (2.35%)  2 0/77 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kazuhiko Yamamoto, Medical Advisor of the Clinical Trial
Organization: Medical Advisor of the Clinical Trial
Phone: +81 3 5800 8825
EMail: yamamoto-tky@umin.ac.jp
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00791999    
Other Study ID Numbers: CDP870-275-08-001
JapicCTI-080665 ( Other Identifier: JAPIC )
First Submitted: November 14, 2008
First Posted: November 17, 2008
Results First Submitted: June 18, 2012
Results First Posted: August 6, 2012
Last Update Posted: August 10, 2012