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The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms in patients with active rheumatoid arthritis (RA) who are incomplete responders to MTX.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo of CDP870+MTX | Placebo Comparator |
| |
| CDP870 200mg+MTX | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo of CDP870 | Drug | Given every 2 weeks until Week22 (SC) |
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| Measure | Description | Time Frame |
|---|---|---|
| ACR20 Responses at Week 24 | 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. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| ACR 20 Responses at Week 12 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soo-kon Lee, MD. PhD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu | 700-721 | South Korea | |||
| Catholic University Hospital of Daegu |
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Dates of the recruitment period : from 03 Nov 2009 to 16 Dec 2010 Types of location : clinic of rheumatology
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | CDP870 200mg+MTX |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| CDP870 200mg |
| Drug |
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week 22(SC) |
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| Methotrexate | Drug | Received treatment with Methotrexate(MTX)for at least 24 weeks prior to the Baseline Visit. The dose and route of administration of MTX had to have been stable for at least 8 weeks prior to the Baseline Visit. The minimum stable dose of MTX allowed is 10mg weekly. |
|
| Week 12 |
| ACR50 Responses at Week 12 | 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. | Week 12 |
| ACR70 Responses at Week 12 | 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. | Week12 |
| ACR50 Responses at Week 24 | Week 24 |
| ACR70 Responses at Week24 | Week 24 |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) | 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. | Baseline and Week 24 |
| Daegu |
| South Korea |
| Eulji University Hospital | Daejeon | 302-799 | South Korea |
| Inha University Hospital | Inchon | South Korea |
| Chonnam National University Hospital | Kwangju | South Korea |
| Pusan National University Hospital | Pusan | South Korea |
| Yonsei University Severance Hospital | Seoul | 120-752 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Catholic University of Korea ST.Mary's Hospital | Seoul | 150-713 | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Hanyang Universoty Hospital | Seoul | South Korea |
| KonKuk University Medical Center | Seoul | South Korea |
| Seoul national univeristy | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
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.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Disease Duration | Mean | Standard Deviation | years |
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| Concomitant MTX dose | Mean | Standard Deviation | mg/week |
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| Number of previous disease-modifying anti-rheumatoid drugs (DMARDs) | Mean | Standard Deviation | drugs/participants |
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| Tender/Painful Joint Count | Tender/Painful joint count range from 0-68 | Mean | Standard Deviation | Joints/participants |
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| Swollen Joint Count | Swollen joint count range from 0-66 | Mean | Standard Deviation | Joints/participants |
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| Health Assessment Questionnaire Disability Index (HAQ-DI) | Total Scale Range: 0(Minimum)-3(Maximum) Lower values represent a better outcome. | Mean | Standard Deviation | scores on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ACR20 Responses at Week 24 | 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. | 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. | Posted | Number | participants | Week 24 |
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| Secondary | ACR 20 Responses at Week 12 | 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. | FAS population | Posted | Number | participants | Week 12 |
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| Secondary | ACR50 Responses at Week 12 | 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. | FAS population | Posted | Number | participants | Week 12 |
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| Secondary | ACR70 Responses at Week 12 | 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. | FAS population | Posted | Number | participants | Week12 |
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| Secondary | ACR50 Responses at Week 24 | FAS population | Posted | Number | participants | Week 24 |
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| Secondary | ACR70 Responses at Week24 | FAS population | Posted | Number | participants | Week 24 |
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| Secondary | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) | 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. | FAS population | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Week 24 |
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36weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 42 | 21 | 42 | ||
| EG001 | 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. | 8 | 85 | 52 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tuberculosis | Infections and infestations | Tuberculosis | Systematic Assessment |
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| Bronchiectasis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Meningitis aseptic | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Tubo-ovarian abscess | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Cerebrovascular spasm | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
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| Abortion induced | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Activated partial thromboplastin time prolonged | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eun Young Cho, Clinical Trial Manager | Korea Otsuka Pharmaceutical | +82-2-3287-9233 | hyerim@otsuka.co.kr |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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| Male |
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