CompletedNCT00791999Updated Aug 10, 2012Results posted

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

A Phase 2/3 interventional study of CDP870 400mg and CDP870 200mg in Rheumatoid Arthritis, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 8 sites in Japan. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2012-08-10.

Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 316
Allocation: Randomized
Ages: 20 Years to 74 Years
Sex: All

Study summary

The objective of this trial is to investigate the efficacy (American College of Rheumatology 20% : ACR20) superiority of two dose regiments of CDP870 versus placebo in combination with MTX in active RA patients who have an incomplete response to MTX. The pharmacokinetics and immunogenicity profile of CDP870 will also be investigated to assess the extrapolability of foreign data to the Japanese population.

Conditions studied

Rheumatoid Arthritis

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Keywords

Rheumatoid Arthritis
Certolizumab Pegol
Cimzia

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 316 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 74 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Subjects must have a diagnosis of adult-onset RA of at least 6 months but not longer than 15 years in duration as defined by the 1987 American College of Rheumatology classification criteria.
Subjects must have active RA disease as defined by:
- At least 9 tender joints and 9 swollen joints
- ESR of 30 mm/hour or CRP of 1.5 mg/dL
Subjects must have received treatment with MTX for at least 6 months prior to the start of study drug administration. The dose of MTX must have remain fixed for at least 2 months prior to the study and the dose of MTX should be within 6 to 8 mg/week.

Exclusion criteria

Exclusion Criteria:

Patients who have a diagnosis of any other inflammatory arthritis
Patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
Patients who currently have, or who have a history of, a demyelinating or convulsive disease of the central nervous system (eg, multiple sclerosis, epilepsy)
Patients who have NYHA (New York Heart Association) Class III or IV congestive heart failure
Patients who currently have, or who have a history of, tuberculosis
Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease)
Patients who currently have, or who have a history of, malignancy
Female patients who are breastfeeding or pregnant, who are of childbearing potential
Patients who previously received treatment with 2 or more anti-TNFα drugs or who previously failed to respond to treatment with 1 or more aint-TNFα drugs.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 316 participants (actual)

Study arms

Experimental
CDP870 100mg
200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
Drug: CDP870 100mg
Experimental
CDP870 200mg
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
Drug: CDP870 200mg
Experimental
CDP870 400mg
400mg CDP870 given every 2 weeks
Drug: CDP870 400mg
Placebo comparator
Placebo
Placebo given every 2 weeks
Drug: Placebo of CDP870

Interventions

DrugCDP870 400mg
400mg CDP870 given every 2 weeks until Week22 (SC)
DrugCDP870 200mg
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week22 (SC)
DrugCDP870 100mg
200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks until Week22 subcutaneously(SC)
DrugPlacebo of CDP870
given every 2 weeks until Week22 (SC)

What researchers measure

Primary outcomes

American College of Rheumatology 20% (ACR20) Response at Week 12
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

Secondary outcomes

American College of Rheumatology 20% (ACR20) Response at Week 24
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

Results

Posted Aug 6, 2012

Participant flow

Subjects were recruited in Japan between 2008 and 2010.

Participant flow — Overall Study
Milestone	CDP870 100mg	CDP870 200mg	CDP870 400mg	Placebo
Started	72	82	85	77
Completed	51	66	65	25
Not completed	21	16	20	52
Withdrew: Protocol planed withdrawal	14	11	11	45
Withdrew: Withdrawal by subject	0	1	0	2
Withdrew: Protocol violation	3	0	1	0
Withdrew: Adverse event	3	3	7	3
Withdrew: Lack of efficacy	0	1	0	2
Withdrew: Reason other than those above	1	0	1	0

Outcome measures

PrimaryAmerican College of Rheumatology 20% (ACR20) Response at Week 12

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
Reported as:: Number · percentage of participants

American College of Rheumatology 20% (ACR20) Response at Week 12
percentage of participants	CDP870 100mg	CDP870 200mg	CDP870 400mg	Placebo
American College of Rheumatology 20% (ACR20) Response at Week 12	62.5	76.8	77.6	28.6

Statistical analysis

CDP870 100mg vs CDP870 200mg vs CDP870 400mg · Regression, Logistic · p = <0.025 (Wald p-values(vs. placebo) for the comparison of the treatment groups have been calculated using logistic regression with factors for treatment.)

SecondaryAmerican College of Rheumatology 20% (ACR20) Response at Week 24

Time frame:: Baseline, Week 24
Reported as:: Number · percentage of participants

American College of Rheumatology 20% (ACR20) Response at Week 24
percentage of participants	CDP870 100mg	CDP870 200mg	CDP870 400mg	Placebo
American College of Rheumatology 20% (ACR20) Response at Week 24	61.1	73.2	71.8	24.7

Statistical analysis

CDP870 100mg vs CDP870 200mg vs CDP870 400mg vs Placebo · Regression, Logistic · p = <0.05 (Wald p-values(vs. placebo) for the comparison of the treatment groups have been calculated using logistic regression with factors for treatment.)

Adverse events

Collected over 24-week double blind phase, from Baseline to Week 24. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
CDP870 100mg	—	3/72 (4.2%)	39/72 (54.2%)
CDP870 200mg	—	4/82 (4.9%)	44/82 (53.7%)
CDP870 400mg	—	5/85 (5.9%)	41/85 (48.2%)
Placebo	—	1/77 (1.3%)	30/77 (39%)

Most frequent serious events

Showing 10 of 15

Most frequent serious events
Event	CDP870 100mg	CDP870 200mg	CDP870 400mg	Placebo
Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders	0/72	0/82	2/85	0/77
Bone marrow failureBlood and lymphatic system disorders	1/72	0/82	0/85	0/77
Enterocolitis viralInfections and infestations	1/72	0/82	0/85	0/77
Spinal compression fractureInjury, poisoning and procedural complications	1/72	0/82	0/85	0/77
Organising pneumoniaRespiratory, thoracic and mediastinal disorders	1/72	0/82	0/85	0/77
Anal fistulaGastrointestinal disorders	0/72	0/82	0/85	1/77
BronchitisInfections and infestations	0/72	1/82	0/85	0/77
PyelonephritisInfections and infestations	0/72	1/82	0/85	0/77
PyomyositisInfections and infestations	0/72	1/82	0/85	0/77
Subcutaneous abscessInfections and infestations	0/72	1/82	0/85	0/77

Most frequent other events

Showing 10 of 20

Most frequent other events
Event	CDP870 100mg	CDP870 200mg	CDP870 400mg	Placebo
NasopharyngitisInfections and infestations	8/72	11/82	13/85	9/77
Rheumatoid arthritisMusculoskeletal and connective tissue disorders	3/72	3/82	2/85	9/77
Hepatic function abnormalHepatobiliary disorders	8/72	3/82	5/85	4/77
PharyngitisInfections and infestations	5/72	5/82	2/85	3/77
Upper respiratory tract infectionInfections and infestations	5/72	2/82	3/85	3/77
Conjunctivitis allergicEye disorders	4/72	2/82	1/85	1/77
EczemaSkin and subcutaneous tissue disorders	4/72	3/82	4/85	2/77
RashSkin and subcutaneous tissue disorders	2/72	4/82	2/85	1/77
PeriodontitisGastrointestinal disorders	1/72	2/82	4/85	2/77
BronchitisInfections and infestations	0/72	1/82	4/85	1/77

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	CDP870 100mg	CDP870 200mg	CDP870 400mg	Placebo	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	61	77	66	68	272
>=65 years	11	5	19	9	44

Age Continuous
Age Continuous(years)	CDP870 100mg	CDP870 200mg	CDP870 400mg	Placebo	Total
Mean	54.3 ± 10.6	50.6 ± 11.4	55.4 ± 10.3	51.9 ± 11.1	53.0 ± 11.0

Sex: Female, Male
Sex: Female, Male(Participants)	CDP870 100mg	CDP870 200mg	CDP870 400mg	Placebo	Total
Female	58	69	69	66	262
Male	14	13	16	11	54

Region of Enrollment
Region of Enrollment(participants)	CDP870 100mg	CDP870 200mg	CDP870 400mg	Placebo	Total
Japan	72	82	85	77	316

Study locations

8 sites

Chubu Region, Japan
Chugoku Region, Japan
Hokkaido Region, Japan
Kanto Region, Japan
Kinki Region, Japan
Kyushuh Region, Japan
Shikoku Region, Japan
Tohoku Region, Japan

References and documents

Publications

Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, Watanabe A, Origasa H, Shoji T, Sakamaki Y, van der Heijde D, Miyasaka N, Koike T. Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: the J-RAPID randomized, placebo-controlled trial. Mod Rheumatol. 2014 Sep;24(5):715-24. doi: 10.3109/14397595.2013.864224. Epub 2013 Dec 9. PubMed 24313916 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00791999
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Collaborators: UCB Japan Co. Ltd.
Responsible party: Sponsor
First posted: Nov 17, 2008
Start date: Nov 2008
Primary completion: Jan 2010
Completion: Jan 2011
Results posted: Aug 6, 2012
Last update: Aug 10, 2012

Study contacts

Katsuhisa Saito

study chair · OPCJ

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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