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A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00993317
Recruitment Status : Completed
First Posted : October 12, 2009
Results First Posted : September 27, 2012
Last Update Posted : September 27, 2012
Sponsor:
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Placebo of CDP870
Drug: CDP870 200mg
Drug: Methotrexate
Enrollment 127
Recruitment Details Dates of the recruitment period : from 03 Nov 2009 to 16 Dec 2010 Types of location : clinic of rheumatology
Pre-assignment Details  
Arm/Group Title Placebo of CDP870+MTX CDP870 200mg+MTX
Hide Arm/Group Description 0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS. Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
Period Title: Overall Study
Started 42 85
Completed 21 60
Not Completed 21 25
Reason Not Completed
Adverse Event             2             4
Lack of Efficacy             18             18
Withdrawal by Subject             0             2
Investigator's opinion             0             1
Early study termination at the site             1             0
Arm/Group Title Placebo of CDP870+MTX CDP870 200mg+MTX Total
Hide Arm/Group Description 0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS. Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml. Total of all reporting groups
Overall Number of Baseline Participants 42 85 127
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 85 participants 127 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
  90.5%
72
  84.7%
110
  86.6%
>=65 years
4
   9.5%
13
  15.3%
17
  13.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 85 participants 127 participants
Female
37
  88.1%
75
  88.2%
112
  88.2%
Male
5
  11.9%
10
  11.8%
15
  11.8%
Disease Duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 85 participants 127 participants
6.0  (5.1) 6.4  (4.2) 6.3  (4.5)
Concomitant MTX dose  
Mean (Standard Deviation)
Unit of measure:  Mg/week
Number Analyzed 42 participants 85 participants 127 participants
13.6  (2.8) 13.4  (2.5) 13.5  (2.6)
Number of previous disease-modifying anti-rheumatoid drugs (DMARDs)  
Mean (Standard Deviation)
Unit of measure:  Drugs/participants
Number Analyzed 42 participants 85 participants 127 participants
3.2  (1.5) 3.3  (1.3) 3.3  (1.4)
Tender/Painful Joint Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Joints/participants
Number Analyzed 42 participants 85 participants 127 participants
25.05  (14.61) 25.04  (14.44) 25.04  (14.44)
[1]
Measure Description: Tender/Painful joint count range from 0-68
Swollen Joint Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Joints/participants
Number Analyzed 42 participants 85 participants 127 participants
17.31  (11.18) 15.96  (8.86) 16.41  (9.66)
[1]
Measure Description: Swollen joint count range from 0-66
Health Assessment Questionnaire Disability Index (HAQ-DI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 42 participants 85 participants 127 participants
1.53  (0.74) 1.43  (0.67) 1.46  (0.69)
[1]
Measure Description: Total Scale Range: 0(Minimum)-3(Maximum) Lower values represent a better outcome.
1.Primary Outcome
Title ACR20 Responses at Week 24
Hide Description Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) Population The full set population will consist of all the subjects who were randomized and treated with the drug and received the primary efficacy evaluation at baseline. In the case of dosing administration error, analyses on the FAS population will be conducted according to the drug the subjects were randomized to.
Arm/Group Title Placebo of CDP870+MTX CDP870 200mg+MTX
Hide Arm/Group Description:
0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
Overall Number of Participants Analyzed 40 81
Measure Type: Number
Unit of Measure: participants
11 54
2.Secondary Outcome
Title ACR 20 Responses at Week 12
Hide Description Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population
Arm/Group Title Placebo of CDP870+MTX CDP870 200mg+MTX
Hide Arm/Group Description:
0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
Overall Number of Participants Analyzed 40 81
Measure Type: Number
Unit of Measure: participants
15 52
3.Secondary Outcome
Title ACR50 Responses at Week 12
Hide Description Achieving ACR50 means 50% or greater improvement in the number of tender joints, a 50% or more improvement in the number of swollen joints and a 50% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population
Arm/Group Title Placebo of CDP870+MTX CDP870 200mg+MTX
Hide Arm/Group Description:
0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
Overall Number of Participants Analyzed 40 81
Measure Type: Number
Unit of Measure: participants
5 21
4.Secondary Outcome
Title ACR70 Responses at Week 12
Hide Description Achieving ACR70 means 70% or greater improvement in the number of tender joints, a 70% or more improvement in the number of swollen joints and a 70% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.
Time Frame Week12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population
Arm/Group Title Placebo of CDP870+MTX CDP870 200mg+MTX
Hide Arm/Group Description:
0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
Overall Number of Participants Analyzed 40 81
Measure Type: Number
Unit of Measure: participants
0 11
5.Secondary Outcome
Title ACR50 Responses at Week 24
Hide Description [Not Specified]
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population
Arm/Group Title Placebo of CDP870+MTX CDP870 200mg+MTX
Hide Arm/Group Description:
0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
Overall Number of Participants Analyzed 40 81
Measure Type: Number
Unit of Measure: participants
8 35
6.Secondary Outcome
Title ACR70 Responses at Week24
Hide Description [Not Specified]
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population
Arm/Group Title Placebo of CDP870+MTX CDP870 200mg+MTX
Hide Arm/Group Description:
0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
Overall Number of Participants Analyzed 40 81
Measure Type: Number
Unit of Measure: participants
1 14
7.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Hide Description Range of HAQ-DI score: 0-3 This outcome measures changes of HAQ-DI score at Week 24 from Baseline. Lower score of HAQ-DI represents a better outcome.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population
Arm/Group Title Placebo of CDP870+MTX CDP870 200mg+MTX
Hide Arm/Group Description:
0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
Overall Number of Participants Analyzed 40 81
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.17  (0.70) -0.54  (0.51)
Time Frame 36weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo of CDP870+MTX CDP870 200mg+MTX
Hide Arm/Group Description 0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS. Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
All-Cause Mortality
Placebo of CDP870+MTX CDP870 200mg+MTX
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo of CDP870+MTX CDP870 200mg+MTX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      8/85 (9.41%)    
Infections and infestations     
Tuberculosis  1  0/42 (0.00%)  0 2/85 (2.35%)  2
Bronchiectasis * 2  0/42 (0.00%)  0 1/85 (1.18%)  1
Meningitis aseptic * 2  0/42 (0.00%)  0 1/85 (1.18%)  1
Pneumonia * 2  0/42 (0.00%)  0 1/85 (1.18%)  1
Pyelonephritis acute * 2  0/42 (0.00%)  0 1/85 (1.18%)  1
Tubo-ovarian abscess * 2  0/42 (0.00%)  0 1/85 (1.18%)  1
Urinary tract infection * 2  0/42 (0.00%)  0 1/85 (1.18%)  1
Injury, poisoning and procedural complications     
Post procedural complication * 2  0/42 (0.00%)  0 1/85 (1.18%)  1
Subdural haematoma * 2  0/42 (0.00%)  0 1/85 (1.18%)  1
Nervous system disorders     
Cerebral haemorrhage * 2  0/42 (0.00%)  0 1/85 (1.18%)  1
Cerebrovascular spasm * 2  0/42 (0.00%)  0 1/85 (1.18%)  1
Dizziness * 2  0/42 (0.00%)  0 1/85 (1.18%)  1
Subarachnoid haemorrhage * 2  0/42 (0.00%)  0 1/85 (1.18%)  1
Surgical and medical procedures     
Abortion induced * 2  0/42 (0.00%)  0 1/85 (1.18%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Tuberculosis
2
Term from vocabulary, MedDRA (12.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo of CDP870+MTX CDP870 200mg+MTX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/42 (50.00%)      52/85 (61.18%)    
Blood and lymphatic system disorders     
Coagulopathy * 1  0/42 (0.00%)  0 3/85 (3.53%)  3
Gastrointestinal disorders     
Abdominal pain upper * 1  2/42 (4.76%)  3 5/85 (5.88%)  5
Dyspepsia * 1  0/42 (0.00%)  0 4/85 (4.71%)  4
Abdominal discomfort * 1  0/42 (0.00%)  0 3/85 (3.53%)  3
Mouth ulceration * 1  0/42 (0.00%)  0 3/85 (3.53%)  3
Diarrhoea * 1  2/42 (4.76%)  2 1/85 (1.18%)  1
General disorders     
Fatigue * 1  1/42 (2.38%)  1 3/85 (3.53%)  3
Injection site pain * 1  2/42 (4.76%)  2 0/85 (0.00%)  0
Infections and infestations     
Upper respiratory tract infection * 1  5/42 (11.90%)  5 12/85 (14.12%)  12
Nasopharyngitis * 1  4/42 (9.52%)  4 10/85 (11.76%)  14
Investigations     
Activated partial thromboplastin time prolonged * 1  0/42 (0.00%)  0 3/85 (3.53%)  3
Nervous system disorders     
Dizziness * 1  2/42 (4.76%)  2 1/85 (1.18%)  1
Respiratory, thoracic and mediastinal disorders     
Cough * 1  1/42 (2.38%)  1 4/85 (4.71%)  4
Oropharyngeal pain * 1  2/42 (4.76%)  2 1/85 (1.18%)  1
Skin and subcutaneous tissue disorders     
Pruritus * 1  0/42 (0.00%)  0 3/85 (3.53%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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: Eun Young Cho, Clinical Trial Manager
Organization: Korea Otsuka Pharmaceutical
Phone: +82-2-3287-9233
EMail: hyerim@otsuka.co.kr
Layout table for additonal information
Responsible Party: Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00993317    
Other Study ID Numbers: 101-KOA-0801i
First Submitted: October 9, 2009
First Posted: October 12, 2009
Results First Submitted: May 22, 2012
Results First Posted: September 27, 2012
Last Update Posted: September 27, 2012