Trial Outcomes & Findings for Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA) (NCT NCT00791921)

NCT ID: NCT00791921

Last Updated: 2012-08-07

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

PHASE3

Target enrollment

230 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2012-08-07

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 200mg 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks	Placebo Placebo of CDP870
Overall Study STARTED	116	114
Overall Study COMPLETED	82	18
Overall Study NOT COMPLETED	34	96

Reasons for withdrawal

Reasons for withdrawal
Measure	CDP870 200mg 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks	Placebo Placebo of CDP870
Overall Study Protocol planed	24	88
Overall Study Withdrawal by Subject	1	2
Overall Study Adverse Event	8	2
Overall Study Lack of Efficacy	0	2
Overall Study Lack of study drug administration	1	1
Overall Study Reason other than those above	0	1

Baseline Characteristics

Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CDP870 200mg n=116 Participants 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks	Placebo n=114 Participants Placebo of CDP870	Total n=230 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	88 Participants n=5 Participants	94 Participants n=7 Participants	182 Participants n=5 Participants
Age, Categorical >=65 years	28 Participants n=5 Participants	20 Participants n=7 Participants	48 Participants n=5 Participants
Age Continuous	56.0 years STANDARD_DEVIATION 10.2 • n=5 Participants	55.4 years STANDARD_DEVIATION 9.8 • n=7 Participants	55.7 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	88 Participants n=7 Participants	171 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	26 Participants n=7 Participants	59 Participants n=5 Participants
Region of Enrollment Japan	116 participants n=5 Participants	114 participants n=7 Participants	230 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: All 230 subjects (116 CDP 200 mg, 114 Placebo) included in the Full Analysis Set (FAS) are included in this analysis

Outcome measures

Outcome measures
Measure	CDP870 200mg n=116 Participants 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks	Placebo n=114 Participants Placebo of CDP870
American College of Rheumatology 20% (ACR20) Response at Week 12	67.2 percentage of participants	14.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All 230 subjects (116 CDP 200 mg, 114 Placebo) included in the Full Analysis Set (FAS) are included in this analysis

Outcome measures

Outcome measures
Measure	CDP870 200mg n=116 Participants 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks	Placebo n=114 Participants Placebo of CDP870
American College of Rheumatology 20% (ACR20) Response at Week 24	63.8 percentage of participants	11.4 percentage of participants

Adverse Events

CDP870 200mg

Serious events: 13 serious events

Other events: 46 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	CDP870 200mg n=116 participants at risk 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks	Placebo n=114 participants at risk Placebo of CDP870
Gastrointestinal disorders Constipation	3.4% 4/116 • Number of events 4 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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% 0/114 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.
Hepatobiliary disorders Hepatic function abnormal	3.4% 4/116 • Number of events 5 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.	3.5% 4/114 • Number of events 4 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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 Nasopharyngitis	17.2% 20/116 • Number of events 23 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.	14.0% 16/114 • Number of events 21 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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 Pharyngitis	5.2% 6/116 • Number of events 6 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.	4.4% 5/114 • Number of events 5 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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 Upper respiratory tract infection	2.6% 3/116 • Number of events 4 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.	3.5% 4/114 • Number of events 4 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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	3.4% 4/116 • Number of events 4 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.	12.3% 14/114 • Number of events 14 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.
Skin and subcutaneous tissue disorders Eczema	5.2% 6/116 • Number of events 6 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.	2.6% 3/114 • Number of events 3 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.
Skin and subcutaneous tissue disorders Rash	8.6% 10/116 • Number of events 11 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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% 0/114 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.
Vascular disorders Hypertension	3.4% 4/116 • Number of events 4 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.	0.88% 1/114 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.

Additional Information

Dr. Kazuhiko Yamamoto, Medical Advisor of the Clinical Trial

Professor, Department of Allergy and Rheumatology, Division of Internal Medicine, Graduate School of Medicine, University of Tokyo

Phone: +81 3 5800 8825

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	CDP870 200mg n=116 participants at risk 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks	Placebo n=114 participants at risk Placebo of CDP870
Blood and lymphatic system disorders Leukopenia	0.00% 0/116 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.	0.88% 1/114 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.
Blood and lymphatic system disorders Thrombocytopenia	0.86% 1/116 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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% 0/114 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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 Ileitis	0.86% 1/116 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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% 0/114 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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 Pancreatitis acute	0.86% 1/116 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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% 0/114 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.
Hepatobiliary disorders Cholecystitis acute	0.86% 1/116 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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% 0/114 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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 Cellulitis	0.00% 0/116 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.	0.88% 1/114 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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 Herpes zoster	0.86% 1/116 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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% 0/114 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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 Influenza	0.00% 0/116 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.	0.88% 1/114 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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 Pneumonia pneumococcal	0.86% 1/116 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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% 0/114 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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 Arthritis bacterial	0.86% 1/116 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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% 0/114 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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 Pneumocystis jiroveci pneumonia	0.86% 1/116 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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% 0/114 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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	1.7% 2/116 • Number of events 2 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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% 0/114 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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	0.86% 1/116 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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% 0/114 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/116 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.	0.88% 1/114 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.
Renal and urinary disorders Calculus ureteric	0.86% 1/116 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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% 0/114 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.86% 1/116 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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% 0/114 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.
Surgical and medical procedures Abortion induced	0.00% 0/116 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.	0.88% 1/114 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.
Vascular disorders Aortic dissection rupture	0.86% 1/116 • Number of events 1 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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% 0/114 • 24-week double blind phase, from Baseline to Week 24 Of the 230 subjects in the Full Analysis Set (FAS), 230 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.