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The primary purpose of this study is to evaluate the safety and efficacy of a once-weekly dose of etanercept for rheumatoid arthritis. Currently, patients in Japan can only use 25 mg etanercept two times a week. If a once-a-week regimen of 50 mg is approved, this would be more convenient for most patients. This once-weekly regimen is used in countries outside of Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Arm 1: Period A-25mg BW; Arm 1: Period B-50mg QW |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept | Drug | Period A: Weeks 1-4: Etanercept 25mg (25mg vial)bi-weekly (BW); Period B: Weeks 5-12: Etanercept 50mg (50mg vial) weekly (QW) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score Using 28-joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4ESR) by Treatment Period. | DAS28-4ESR is a clinical index of rheumatoid arthritis disease activity based on information from swollen joints, tender joints, acute phase response (Erythrocyte Sedimentation Rate) and general health. DAS28-4ESR scores range from 0 - 10, where a score of less than or equal to 3.2 implies well controlled disease and greater than or equal to 5.1 implies active disease. In this analysis, the DAS28-4ESR is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12). | weeks 4 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. In this analysis, the AUC is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12). Blood samples were taken on day 0 of PK analysis and collected every day after for 7 days for weeks 4 and 12. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nunoya-cho Goshogawara | Aomori | 037-0053 | Japan | |||
Subjects were screened up to 4 weeks and received 25 mg etanercept (as test article) BW for 4 weeks during treatment period A. At the end of the period A, the same cohort of subjects entered period B and received etanercept 50 mg (as test article) QW for 8 weeks to assess the efficacy and safety of a QW regimen.
Subjects were recruited in Japan from January 2007 to September 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept (ETN) | Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW) Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period A - Weeks 1-4 |
|
| ||||||||||||||||||
| Treatment Period B - Weeks 5-12 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept (ETN) | Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW) Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Disease Activity Score Using 28-joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4ESR) by Treatment Period. | DAS28-4ESR is a clinical index of rheumatoid arthritis disease activity based on information from swollen joints, tender joints, acute phase response (Erythrocyte Sedimentation Rate) and general health. DAS28-4ESR scores range from 0 - 10, where a score of less than or equal to 3.2 implies well controlled disease and greater than or equal to 5.1 implies active disease. In this analysis, the DAS28-4ESR is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12). | The analysis population was modified intent to treat (mITT), which included all patients who completed the 25 mg BW dose treatment period and received at least 1 dose of 50 mg OW. Data on observed cases: 41 patients from ENT 25 mg BW (week 4) and 39 patients from ETN 50 mg OW (week 12). | Posted | Dec 2008 | Mean | Standard Deviation | units on scale | weeks 4 and 12 |
|
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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 | Etanercept (ETN) | Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW) Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Calculus Ureteric / Pyelonephritis | Renal and urinary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| U. S. Contact Center | Wyeth | clintrialresults@wyeth.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| 7 days after week 4 and 7 days after week 12 |
| Kokubu, Kurume |
| Fukuoka |
| 839-0863 |
| Japan |
| Inomachi Takasaki | Gunma | 370-0004 | Japan |
| Higashiuneno Kawanishi | Hyōgo | 666-0195 | Japan |
| Mukogawa-cho, Nishinomiya | Hyōgo | 663-8501 | Japan |
| Kamiyokoba, Tsukuba | Ibaraki | 305-0854 | Japan |
| Douhaku, Suzuka | Mie-ken | 513-0824 | Japan |
| Hazama, Isobe-cho, Shima | Mie-ken | 517-0214 | Japan |
| Hisai Myojin-cho, Tsu | Mie-ken | 514-1101 | Japan |
| Yamato, Sasebo | Nagasaki | 857-1195 | Japan |
| Higashizuka, Kurashiki | Okayama-ken | 712-8044 | Japan |
| Toranomon, Minato-ku | Tokyo | 105-0001 | Japan |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | Etanercept (ETN) | Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW) Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW) |
|
|
|
| Secondary | Area Under the Concentration-Time Curve (AUC) | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. In this analysis, the AUC is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12). Blood samples were taken on day 0 of PK analysis and collected every day after for 7 days for weeks 4 and 12. | The analysis population was the Pharmacokinetic (PK) subset, which included all patients who completed the 25 mg BW dose treatment period, received at least 1 dose of 50 mg QW and elected to participate in the PK assessment. Data on observed cases: 18 patients from ETN 25 mg BW (week 4) and 17 patients from ETN 50 mg QW (week 12). | Posted | Dec 2008 | Mean | Standard Deviation | ug*Day/mL | 7 days after week 4 and 7 days after week 12 |
|
|
|
| 1 |
| 29 |
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Infections and Infestations | Infections and infestations | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Parotid gland enlargement | Gastrointestinal disorders | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Tongue ulceration | Gastrointestinal disorders | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Odema peripheral | General disorders | Non-systematic Assessment |
|
| White blood cell count increase | Investigations | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Photodermatosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |