| ID | Type | Description | Link |
|---|---|---|---|
| C0168Z05 | Other Identifier | Centocor Ortho Biotech Services, L.L.C. |
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| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
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The purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanercept or adalimumab in addition to methotrexate.
This is a Phase 4, multi center, open-label, assessor blinded, switch study of infliximab in patients with active rheumatoid arthritis who are receiving methotrexate and are having an inadequate response to their current treatment with etanercept or adalimumab. The last dose of etanercept must have been at least 1 week but not more than 2 weeks prior to the first infliximab study infusion. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to the first infliximab study infusion. The study will be conducted for 30 weeks and will include 200 patients. All eligible patients will receive 3 mg/kg infliximab infusions (drug given into a vein) at weeks 0, 2, and 6 and every 8 weeks thereafter, if they achieve a European League Against Rheumatism (EULAR) response on their current dose of infliximab. Patients who do not achieve a EULAR response will increase their dose from 3mg/kg to 5 mg/kg at week 14. Patients who do not achieve a EULAR response at week 22 will increase from either 3 mg/kg to 5 mg/kg or from 5mg/kg to 7 mg/kg. The last study infusion will take place at week 22. The last study visit for effectiveness evaluations will take place at week 26. A week 30 follow-up visit will be performed for adverse events and tuberculosis evaluations, health economics assessments, and review of concomitant medications. All patients who end the study early will be required to complete all assessments. Patients will receive 3 mg/kg infliximab infusions at weeks 0, 2, and 6. If patients achieve European League Against Rheumatism (EULAR) response, they will remain on their current dose. Patients who do not demonstrate a EULAR response will increase their infliximab dose from 3 mg/kg to 5 mg/kg at week 14. At week 22, patients will also increase their infliximab dose from 3 mg/kg to 5mg/kg or from 5 mg/kg to 7mg/kg if they do not demonstrate a EULAR response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Other | Infliximab3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Biological | 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10 | Percent of patients who achieved EULAR response at Week 10. EULAR response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). At a given visit, patients with a DAS28 score of ≤ 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is greater than 0.6; Or patients with a DAS28 score > 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is > 1.2. | Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase | Percent of patients who achieved EULAR response at Week 10 and maintained through Week 26 without infliximab dose increase | Week 26 |
| Percent of Patients Who Achieved EULAR Response at Week 26, Regardless of EULAR Response Status at Weeks 10, 14, and 22, With or Without Dose Increase Prior to Week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor Ortho Biotech Services, L.L.C. Clinical Trial | Centocor Ortho Biotech Services, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25050591 | Derived | Fleischmann R, Goldman JA, Leirisalo-Repo M, Zanetakis E, El-Kadi H, Kellner H, Bolce R, DeHoratius R, Wang J, Decktor D. Infliximab efficacy in rheumatoid arthritis after an inadequate response to etanercept or adalimumab: results of a target-driven active switch study. Curr Med Res Opin. 2014 Nov;30(11):2139-49. doi: 10.1185/03007995.2014.942416. Epub 2014 Jul 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Infliximab | Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Percent of patients who achieved EULAR response at Week 26, regardless of EULAR response status at Weeks 10, 14, and 22, with or without dose increase prior to Week 26 |
| Week 26 |
| Change From Baseline in Physical Function (HAQ) | Change from baseline in physical function (HAQ) at Week 10. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 10 value minus baseline value. A negative value in change from baseline indicates an improvement. | Week 10 |
| Change From Baseline in Physical Function (HAQ) | Change from baseline in physical function (HAQ) at Week 26. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 26 value minus baseline value. A negative value in change from baseline indicates an improvement. | Week 26 |
| Percent of Patients Who Achieved ACR20 at Week 10 | Percent of patients who achieved ACR20 at Week 10. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient's assessment of pain visual analog scale (VAS), Patient's global assessment of disease activity (VAS), Evaluator's global assessment of disease activity (VAS), Patient's assessment of physical function as measured by the HAQ disability index, and CRP. | Week 10 |
| Percent of Patients Who Achieved ACR20 at Weeks 26. | Percent of patients who achieved ACR20 at Weeks 26. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient's assessment of pain visual analog scale (VAS), Patient's global assessment of disease activity (VAS), Evaluator's global assessment of disease activity (VAS), Patient's assessment of physical function as measured by the HAQ disability index, and CRP. | Week 26 |
| Paradise Valley |
| Arizona |
| United States |
| Tucson | Arizona | United States |
| Santa Monica | California | United States |
| Bridgeport | Connecticut | United States |
| Lewes | Delaware | United States |
| Boca Raton | Florida | United States |
| Palm Harbor | Florida | United States |
| Tamarac | Florida | United States |
| Vero Beach | Florida | United States |
| Atlanta | Georgia | United States |
| Moline | Illinois | United States |
| Springfield | Illinois | United States |
| Lexington | Kentucky | United States |
| Wheaton | Maryland | United States |
| Saint Clair Shores | Michigan | United States |
| Eagan | Minnesota | United States |
| Springfield | Missouri | United States |
| St Louis | Missouri | United States |
| Berkeley Heights | New Jersey | United States |
| Freehold | New Jersey | United States |
| Albany | New York | United States |
| Syracuse | New York | United States |
| Chapel Hill | North Carolina | United States |
| Columbus | Ohio | United States |
| Mayfield | Ohio | United States |
| Middleburg Heights | Ohio | United States |
| Tulsa | Oklahoma | United States |
| Allentown | Pennsylvania | United States |
| Duncansville | Pennsylvania | United States |
| Wexford | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Greenville | South Carolina | United States |
| Jackson | Tennessee | United States |
| Nashville | Tennessee | United States |
| Amarillo | Texas | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| Mesquite | Texas | United States |
| Temple | Texas | United States |
| Tyler | Texas | United States |
| Burke | Virginia | United States |
| Reston | Virginia | United States |
| Seattle | Washington | United States |
| Graz-Eggenberg | Austria |
| Vienna | Austria |
| Vancouver | British Columbia | Canada |
| Winnipeg | Manitoba | Canada |
| St. John's | Newfoundland and Labrador | Canada |
| Toronto | Ontario | Canada |
| Hamilton Ontario | Canada |
| Helsinki | Finland |
| Bordeaux | France |
| Limoges | France |
| Montivilliers | France |
| Orléans | France |
| Frankfurt | Germany |
| Holdenfelde | Germany |
| Leipzig | Germany |
| München | Germany |
| Ratingen | Germany |
| Ashkelon | Israel |
| Beer Yaakov | Israel |
| Haifa | Israel |
| Kfar Saba | Israel |
| Ramat Gan | Israel |
| Rehovot | Israel |
| Tel Aviv | Israel |
| Alkmaar | Netherlands |
| Madrid | Spain |
| Oviedo | Spain |
| Santiago de Compostela | Spain |
| Leeds | United Kingdom |
| London | United Kingdom |
| Wigan | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Infliximab | Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response |
| 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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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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 | Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10 | Percent of patients who achieved EULAR response at Week 10. EULAR response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). At a given visit, patients with a DAS28 score of ≤ 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is greater than 0.6; Or patients with a DAS28 score > 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is > 1.2. | The evaluable population was the subset of the mITT population (included the enrolled patients who received at least 1 dose of study medication) after excluding all 6 patients from Site 8631 where significant trial misconducts were identified. | Posted | Number | Percentage | Week 10 |
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| Secondary | Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase | Percent of patients who achieved EULAR response at Week 10 and maintained through Week 26 without infliximab dose increase | Posted | Number | percentage | Week 26 |
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| Secondary | Percent of Patients Who Achieved EULAR Response at Week 26, Regardless of EULAR Response Status at Weeks 10, 14, and 22, With or Without Dose Increase Prior to Week 26 | Percent of patients who achieved EULAR response at Week 26, regardless of EULAR response status at Weeks 10, 14, and 22, with or without dose increase prior to Week 26 | Posted | Number | percentage | Week 26 |
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| Secondary | Change From Baseline in Physical Function (HAQ) | Change from baseline in physical function (HAQ) at Week 10. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 10 value minus baseline value. A negative value in change from baseline indicates an improvement. | Posted | Mean | Standard Deviation | scale -3 to 3 | Week 10 |
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| Secondary | Change From Baseline in Physical Function (HAQ) | Change from baseline in physical function (HAQ) at Week 26. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 26 value minus baseline value. A negative value in change from baseline indicates an improvement. | Posted | Mean | Standard Deviation | scale -3 to 3 | Week 26 |
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| Secondary | Percent of Patients Who Achieved ACR20 at Week 10 | Percent of patients who achieved ACR20 at Week 10. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient's assessment of pain visual analog scale (VAS), Patient's global assessment of disease activity (VAS), Evaluator's global assessment of disease activity (VAS), Patient's assessment of physical function as measured by the HAQ disability index, and CRP. | Posted | Number | percentage | Week 10 |
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| Secondary | Percent of Patients Who Achieved ACR20 at Weeks 26. | Percent of patients who achieved ACR20 at Weeks 26. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient's assessment of pain visual analog scale (VAS), Patient's global assessment of disease activity (VAS), Evaluator's global assessment of disease activity (VAS), Patient's assessment of physical function as measured by the HAQ disability index, and CRP. | Posted | Number | percentage | Week 26 |
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All untoward events occurring between the time of obtaining informed consent through Week 30 or early termination were collected, regardless of causality.
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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 | Infliximab | Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response | 10 | 203 | 54 | 203 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Atrioventricular Block Complete | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Cardiogenic Shock | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Congestive Cardiomyopathy | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Multi-Organ Failure | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Metastatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
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| Completed Suicide | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Clinical Research - Medical Affairs | Centocor Ortho Biotech, Inc. | 215-325-6811 | Ddeckto2@its.jnj.com |
| 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 |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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