Trial Outcomes & Findings for A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis (NCT NCT00993317)
NCT ID: NCT00993317
Last Updated: 2012-09-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
127 participants
Primary outcome timeframe
Week 24
Results posted on
2012-09-27
Participant Flow
Dates of the recruitment period : from 03 Nov 2009 to 16 Dec 2010 Types of location : clinic of rheumatology
Participant milestones
| Measure |
Placebo of CDP870+MTX
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.
|
CDP870 200mg+MTX
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 Study
STARTED
|
42
|
85
|
|
Overall Study
COMPLETED
|
21
|
60
|
|
Overall Study
NOT COMPLETED
|
21
|
25
|
Reasons for withdrawal
| Measure |
Placebo of CDP870+MTX
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.
|
CDP870 200mg+MTX
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 Study
Adverse Event
|
2
|
4
|
|
Overall Study
Lack of Efficacy
|
18
|
18
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Investigator's opinion
|
0
|
1
|
|
Overall Study
Early study termination at the site
|
1
|
0
|
Baseline Characteristics
A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Placebo of CDP870+MTX
n=42 Participants
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.
|
CDP870 200mg+MTX
n=85 Participants
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
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Disease Duration
|
6.0 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
6.4 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
6.3 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Concomitant MTX dose
|
13.6 mg/week
STANDARD_DEVIATION 2.8 • n=5 Participants
|
13.4 mg/week
STANDARD_DEVIATION 2.5 • n=7 Participants
|
13.5 mg/week
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Number of previous disease-modifying anti-rheumatoid drugs (DMARDs)
|
3.2 drugs/participants
STANDARD_DEVIATION 1.5 • n=5 Participants
|
3.3 drugs/participants
STANDARD_DEVIATION 1.3 • n=7 Participants
|
3.3 drugs/participants
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Tender/Painful Joint Count
|
25.05 Joints/participants
STANDARD_DEVIATION 14.61 • n=5 Participants
|
25.04 Joints/participants
STANDARD_DEVIATION 14.44 • n=7 Participants
|
25.04 Joints/participants
STANDARD_DEVIATION 14.44 • n=5 Participants
|
|
Swollen Joint Count
|
17.31 Joints/participants
STANDARD_DEVIATION 11.18 • n=5 Participants
|
15.96 Joints/participants
STANDARD_DEVIATION 8.86 • n=7 Participants
|
16.41 Joints/participants
STANDARD_DEVIATION 9.66 • n=5 Participants
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI)
|
1.53 scores on a scale
STANDARD_DEVIATION 0.74 • n=5 Participants
|
1.43 scores on a scale
STANDARD_DEVIATION 0.67 • n=7 Participants
|
1.46 scores on a scale
STANDARD_DEVIATION 0.69 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo of CDP870+MTX
n=40 Participants
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.
|
CDP870 200mg+MTX
n=81 Participants
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.
|
|---|---|---|
|
ACR20 Responses at Week 24
|
11 participants
|
54 participants
Interval 2.291 to 12.137
|
SECONDARY outcome
Timeframe: Week 12Population: FAS population
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.
Outcome measures
| Measure |
Placebo of CDP870+MTX
n=40 Participants
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.
|
CDP870 200mg+MTX
n=81 Participants
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.
|
|---|---|---|
|
ACR 20 Responses at Week 12
|
15 participants
|
52 participants
|
SECONDARY outcome
Timeframe: Week 12Population: FAS population
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.
Outcome measures
| Measure |
Placebo of CDP870+MTX
n=40 Participants
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.
|
CDP870 200mg+MTX
n=81 Participants
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.
|
|---|---|---|
|
ACR50 Responses at Week 12
|
5 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Week12Population: FAS population
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.
Outcome measures
| Measure |
Placebo of CDP870+MTX
n=40 Participants
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.
|
CDP870 200mg+MTX
n=81 Participants
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.
|
|---|---|---|
|
ACR70 Responses at Week 12
|
0 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Week 24Population: FAS population
Outcome measures
| Measure |
Placebo of CDP870+MTX
n=40 Participants
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.
|
CDP870 200mg+MTX
n=81 Participants
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.
|
|---|---|---|
|
ACR50 Responses at Week 24
|
8 participants
|
35 participants
|
SECONDARY outcome
Timeframe: Week 24Population: FAS population
Outcome measures
| Measure |
Placebo of CDP870+MTX
n=40 Participants
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.
|
CDP870 200mg+MTX
n=81 Participants
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.
|
|---|---|---|
|
ACR70 Responses at Week24
|
1 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS population
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.
Outcome measures
| Measure |
Placebo of CDP870+MTX
n=40 Participants
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.
|
CDP870 200mg+MTX
n=81 Participants
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.
|
|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
|
-0.17 scores on a scale
Standard Deviation 0.70
|
-0.54 scores on a scale
Standard Deviation 0.51
|
Adverse Events
Placebo of CDP870+MTX
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
CDP870 200mg+MTX
Serious events: 8 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo of CDP870+MTX
n=42 participants at risk
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.
|
CDP870 200mg+MTX
n=85 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Tuberculosis
|
0.00%
0/42 • 36weeks
|
2.4%
2/85 • Number of events 2 • 36weeks
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/42 • 36weeks
|
1.2%
1/85 • Number of events 1 • 36weeks
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/42 • 36weeks
|
1.2%
1/85 • Number of events 1 • 36weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/42 • 36weeks
|
1.2%
1/85 • Number of events 1 • 36weeks
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/42 • 36weeks
|
1.2%
1/85 • Number of events 1 • 36weeks
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/42 • 36weeks
|
1.2%
1/85 • Number of events 1 • 36weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/42 • 36weeks
|
1.2%
1/85 • Number of events 1 • 36weeks
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/42 • 36weeks
|
1.2%
1/85 • Number of events 1 • 36weeks
|
|
Nervous system disorders
Cerebrovascular spasm
|
0.00%
0/42 • 36weeks
|
1.2%
1/85 • Number of events 1 • 36weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/42 • 36weeks
|
1.2%
1/85 • Number of events 1 • 36weeks
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/42 • 36weeks
|
1.2%
1/85 • Number of events 1 • 36weeks
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/42 • 36weeks
|
1.2%
1/85 • Number of events 1 • 36weeks
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/42 • 36weeks
|
1.2%
1/85 • Number of events 1 • 36weeks
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/42 • 36weeks
|
1.2%
1/85 • Number of events 1 • 36weeks
|
Other adverse events
| Measure |
Placebo of CDP870+MTX
n=42 participants at risk
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.
|
CDP870 200mg+MTX
n=85 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
11.9%
5/42 • Number of events 5 • 36weeks
|
14.1%
12/85 • Number of events 12 • 36weeks
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
4/42 • Number of events 4 • 36weeks
|
11.8%
10/85 • Number of events 14 • 36weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
2/42 • Number of events 3 • 36weeks
|
5.9%
5/85 • Number of events 5 • 36weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/42 • 36weeks
|
4.7%
4/85 • Number of events 4 • 36weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/42 • 36weeks
|
3.5%
3/85 • Number of events 3 • 36weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/42 • 36weeks
|
3.5%
3/85 • Number of events 3 • 36weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
2/42 • Number of events 2 • 36weeks
|
1.2%
1/85 • Number of events 1 • 36weeks
|
|
General disorders
Fatigue
|
2.4%
1/42 • Number of events 1 • 36weeks
|
3.5%
3/85 • Number of events 3 • 36weeks
|
|
General disorders
Injection site pain
|
4.8%
2/42 • Number of events 2 • 36weeks
|
0.00%
0/85 • 36weeks
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/42 • 36weeks
|
3.5%
3/85 • Number of events 3 • 36weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/42 • Number of events 1 • 36weeks
|
4.7%
4/85 • Number of events 4 • 36weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
2/42 • Number of events 2 • 36weeks
|
1.2%
1/85 • Number of events 1 • 36weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/42 • 36weeks
|
3.5%
3/85 • Number of events 4 • 36weeks
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/42 • 36weeks
|
3.5%
3/85 • Number of events 3 • 36weeks
|
|
Nervous system disorders
Dizziness
|
4.8%
2/42 • Number of events 2 • 36weeks
|
1.2%
1/85 • Number of events 1 • 36weeks
|
Additional Information
Eun Young Cho, Clinical Trial Manager
Korea Otsuka Pharmaceutical
Phone: +82-2-3287-9233
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place