Trial Outcomes & Findings for Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA) (NCT NCT00791999)

NCT ID: NCT00791999

Last Updated: 2012-08-10

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

316 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2012-08-10

Participant Flow

Subjects were recruited in Japan between 2008 and 2010.

Participant flow results are based on the safety set.

Participant milestones

Participant milestones
Measure	CDP870 100mg 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks	CDP870 200mg 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks	CDP870 400mg 400mg CDP870 given every 2 weeks	Placebo Placebo given every 2 weeks
Overall Study STARTED	72	82	85	77
Overall Study COMPLETED	51	66	65	25
Overall Study NOT COMPLETED	21	16	20	52

Reasons for withdrawal

Reasons for withdrawal
Measure	CDP870 100mg 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks	CDP870 200mg 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks	CDP870 400mg 400mg CDP870 given every 2 weeks	Placebo Placebo given every 2 weeks
Overall Study Protocol planed withdrawal	14	11	11	45
Overall Study Withdrawal by Subject	0	1	0	2
Overall Study Protocol Violation	3	0	1	0
Overall Study Adverse Event	3	3	7	3
Overall Study Lack of Efficacy	0	1	0	2
Overall Study Reason other than those above	1	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CDP870 100mg n=72 Participants 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks	CDP870 200mg n=82 Participants 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks	CDP870 400mg n=85 Participants 400mg CDP870 given every 2 weeks	Placebo n=77 Participants Placebo given every 2 weeks	Total n=316 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	61 Participants n=5 Participants	77 Participants n=7 Participants	66 Participants n=5 Participants	68 Participants n=4 Participants	272 Participants n=21 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	5 Participants n=7 Participants	19 Participants n=5 Participants	9 Participants n=4 Participants	44 Participants n=21 Participants
Age Continuous	54.3 years STANDARD_DEVIATION 10.6 • n=5 Participants	50.6 years STANDARD_DEVIATION 11.4 • n=7 Participants	55.4 years STANDARD_DEVIATION 10.3 • n=5 Participants	51.9 years STANDARD_DEVIATION 11.1 • n=4 Participants	53.0 years STANDARD_DEVIATION 11.0 • n=21 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	69 Participants n=7 Participants	69 Participants n=5 Participants	66 Participants n=4 Participants	262 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	13 Participants n=7 Participants	16 Participants n=5 Participants	11 Participants n=4 Participants	54 Participants n=21 Participants
Region of Enrollment Japan	72 participants n=5 Participants	82 participants n=7 Participants	85 participants n=5 Participants	77 participants n=4 Participants	316 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: 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

Outcome measures

Outcome measures
Measure	CDP870 100mg n=72 Participants 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks	CDP870 200mg n=82 Participants 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks	CDP870 400mg n=85 Participants 400mg CDP870 given every 2 weeks	Placebo n=77 Participants Placebo given every 2 weeks
American College of Rheumatology 20% (ACR20) Response at Week 12	62.5 percentage of participants	76.8 percentage of participants	77.6 percentage of participants	28.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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

Outcome measures

Outcome measures
Measure	CDP870 100mg n=72 Participants 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks	CDP870 200mg n=82 Participants 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks	CDP870 400mg n=85 Participants 400mg CDP870 given every 2 weeks	Placebo n=77 Participants Placebo given every 2 weeks
American College of Rheumatology 20% (ACR20) Response at Week 24	61.1 percentage of participants	73.2 percentage of participants	71.8 percentage of participants	24.7 percentage of participants

Adverse Events

CDP870 100mg

Serious events: 3 serious events

Other events: 39 other events

Deaths: 0 deaths

CDP870 200mg

Serious events: 4 serious events

Other events: 44 other events

Deaths: 0 deaths

CDP870 400mg

Serious events: 5 serious events

Other events: 41 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Kazuhiko Yamamoto, Medical Advisor of the Clinical Trial

Medical Advisor of the Clinical Trial

Phone: +81 3 5800 8825

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	CDP870 100mg n=72 participants at risk 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks	CDP870 200mg n=82 participants at risk 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks	CDP870 400mg n=85 participants at risk 400mg CDP870 given every 2 weeks	Placebo n=77 participants at risk Placebo given every 2 weeks
Blood and lymphatic system disorders Bone marrow failure	1.4% 1/72 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/82 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/85 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/77 • 24-week double blind phase, from Baseline to Week 24 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.
Cardiac disorders Acute myocardial infarction	0.00% 0/72 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/82 • 24-week double blind phase, from Baseline to Week 24 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.	1.2% 1/85 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/77 • 24-week double blind phase, from Baseline to Week 24 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.
Eye disorders Corneal perforation	0.00% 0/72 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/82 • 24-week double blind phase, from Baseline to Week 24 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.	1.2% 1/85 • Number of events 2 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/77 • 24-week double blind phase, from Baseline to Week 24 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.
Gastrointestinal disorders Anal fistula	0.00% 0/72 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/82 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/85 • 24-week double blind phase, from Baseline to Week 24 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.	1.3% 1/77 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 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.
Infections and infestations Bronchitis	0.00% 0/72 • 24-week double blind phase, from Baseline to Week 24 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.	1.2% 1/82 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/85 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/77 • 24-week double blind phase, from Baseline to Week 24 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.
Infections and infestations Pyelonephritis	0.00% 0/72 • 24-week double blind phase, from Baseline to Week 24 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.	1.2% 1/82 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/85 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/77 • 24-week double blind phase, from Baseline to Week 24 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.
Infections and infestations Pyomyositis	0.00% 0/72 • 24-week double blind phase, from Baseline to Week 24 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.	1.2% 1/82 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/85 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/77 • 24-week double blind phase, from Baseline to Week 24 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.
Infections and infestations Subcutaneous abscess	0.00% 0/72 • 24-week double blind phase, from Baseline to Week 24 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.	1.2% 1/82 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/85 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/77 • 24-week double blind phase, from Baseline to Week 24 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.
Infections and infestations Urosepsis	0.00% 0/72 • 24-week double blind phase, from Baseline to Week 24 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.	1.2% 1/82 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/85 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/77 • 24-week double blind phase, from Baseline to Week 24 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.
Infections and infestations Enterocolitis viral	1.4% 1/72 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/82 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/85 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/77 • 24-week double blind phase, from Baseline to Week 24 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.
Injury, poisoning and procedural complications Spinal compression fracture	1.4% 1/72 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/82 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/85 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/77 • 24-week double blind phase, from Baseline to Week 24 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.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/72 • 24-week double blind phase, from Baseline to Week 24 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.	1.2% 1/82 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 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.	1.2% 1/85 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/77 • 24-week double blind phase, from Baseline to Week 24 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.
Nervous system disorders Meningitis noninfective	0.00% 0/72 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/82 • 24-week double blind phase, from Baseline to Week 24 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.	1.2% 1/85 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/77 • 24-week double blind phase, from Baseline to Week 24 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.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/72 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/82 • 24-week double blind phase, from Baseline to Week 24 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.	2.4% 2/85 • Number of events 2 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/77 • 24-week double blind phase, from Baseline to Week 24 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.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	1.4% 1/72 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/82 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/85 • 24-week double blind phase, from Baseline to Week 24 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.	0.00% 0/77 • 24-week double blind phase, from Baseline to Week 24 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.