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This study is being carried out to investigate if AZD5672 is effective in treating Rheumatoid Arthritis (RA) and if so how it compares to placebo (a substance which does not have any action) and etanercept (a medicine already available to treat Rheumatoid Arthritis) when added to treatment with methotrexate. The purpose of this study is also to find out which dose of AZD5672 is the most effective at treating RA and to find out how well the body tolerates AZD5672 when taken for up to 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Experimental | 20mg |
|
| 3 | Experimental | 50mg |
|
| 4 | Experimental | 100mg |
|
| 5 | Experimental | 150mg |
|
| 6 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5672 | Drug | 20 mg oral, once daily |
| |
| Etanercept |
| Measure | Description | Time Frame |
|---|---|---|
| American College of Rheumatology 20 Response (ACR20) | The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 12 Weeks' treatment. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| American College of Rheumatology 50 Response (ACR50) | The number of participants with greater to or equal to 50% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 12 Weeks' treatment. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Layton | AstraZeneca | Study Director |
| Paul P Tak, MD, PhD | University of Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Blagoevgrad | Bulgaria | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20662070 | Derived | Gerlag DM, Hollis S, Layton M, Vencovsky J, Szekanecz Z, Braddock M, Tak PP; ESCAPE Study Group. Preclinical and clinical investigation of a CCR5 antagonist, AZD5672, in patients with rheumatoid arthritis receiving methotrexate. Arthritis Rheum. 2010 Nov;62(11):3154-60. doi: 10.1002/art.27652. |
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Male or female adult patients with active rheumatoid arthritis (on background treatment of methotrexate) were randomly assigned to receive AZD5672 at 20, 50, 100 or 150 mg once daily, placebo or etanercept.
It was planned to randomise approx 360 patients in total, 60 to the open-label etanercept arm and 300 in total to the AZD5672 or placebo arms.
The first participant enrolled on 01 July 2008, and the last participant completed the study on 08 April 2009. Participants were recruited from 61 centres in 14 countries in Europe, Southern Africa and South America.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD5672 20 mg | AZD5672 20 mg, oral tablets, once daily, double-blinded |
| FG001 | AZD5672 50 mg | AZD5672 50 mg, oral tablets, once daily, double-blinded |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
50 mg, subcutaneous injection, weekly |
|
|
| Placebo | Drug | placebo, oral, once daily |
|
| AZD5672 | Drug | 50 mg oral, once daily |
|
| AZD5672 | Drug | 100 mg oral, once daily |
|
| AZD5672 | Drug | 150 mg oral, once daily |
|
| American College of Rheumatology 70 Response (ACR70) | The number of participants with greater to or equal to 70% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 12 Weeks' treatment. | 12 weeks |
| Disease Activity Score (Based on 28 Joint Count) (DAS28) | Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of disease activity; and ESR) after 12 Weeks' treatment. A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms. | Baseline to 12 Weeks |
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | Change from baseline in HAQ-DI (a measure of patients assessment of physical function scored between zero and 3) after 6 months' treatment, calculated as score at 12 Weeks minus score at baseline. A change of zero indicates no effect of treatment and a negative change of 0.22 or greater indicates an improvement in symptoms. The HAQ-DI scale runs from 0 to 3, with higher scores indicating greater disability. | Baseline to 12 Weeks |
| Plovdiv |
| Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Medellín | Colombia | Colombia |
| Research Site | Bogotá | Colombia |
| Research Site | Bucaramanga | Colombia |
| Research Site | Česká Lípa | Czechia |
| Research Site | České Budějovice | Czechia |
| Research Site | Hlučín | Czechia |
| Research Site | Pardubice | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Praha 11 - Chodov | Czechia |
| Research Site | Zlín | Czechia |
| Research Site | Békéscsaba | Hungary |
| Research Site | Budapest | Hungary |
| Research Site | Debrecen | Hungary |
| Research Site | Kecskemét | Hungary |
| Research Site | Makó | Hungary |
| Research Site | Sopron | Hungary |
| Research Site | Siena | SI | Italy |
| Research Site | Valmiera | Latvia |
| Research Site | Birkirkara | Malta |
| Research Site | Bialystok | Poland |
| Research Site | Działdowo | Poland |
| Research Site | Krakow | Poland |
| Research Site | Lublin | Poland |
| Research Site | Sopot | Poland |
| Research Site | Szczecin | Poland |
| Research Site | Torun | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Wroclaw | Poland |
| Research Site | Brasov | Romania |
| Research Site | Bucharest | Romania |
| Research Site | Ploieşti | Romania |
| Research Site | Saint Petersburg | Russia |
| Research Site | Yaroslavl | Russia |
| Research Site | Belgrade | Serbia |
| Research Site | Niška Banja | Serbia |
| Research Site | Banská Bystrica | Slovakia |
| Research Site | Bratislava | Slovakia |
| Research Site | Piešťany | Slovakia |
| Research Site | Pretoria | Gauteng | South Africa |
| Research Site | Durban | KwaZulu-Natal | South Africa |
| Research Site | Cape Town | Western Cape | South Africa |
| Research Site | Donetsk | Ukraine |
| Research Site | Ivano-Frankivsk | Ukraine |
| Research Site | Kiev | Ukraine |
| Research Site | Kyiv | Ukraine |
| Research Site | Simferopol | Ukraine |
| FG002 | AZD5672 100 mg | AZD5672 100 mg, oral tablets, once daily, double-blinded |
| FG003 | AZD5672 150 mg | AZD5672 150 mg, oral tablets, once daily, double-blinded |
| FG004 | Placebo | Placebo to AZD5672, oral tablets, once daily, double-blinded |
| FG005 | Etanercept | Etanercept 50 mg, subcutaneous injection, once weekly, open-label |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD5672 20 mg | AZD5672 20 mg, oral tablets, once daily, double-blinded |
| BG001 | AZD5672 50 mg | AZD5672 50 mg, oral tablets, once daily, double-blinded |
| BG002 | AZD5672 100 mg | AZD5672 100 mg, oral tablets, once daily, double-blinded |
| BG003 | AZD5672 150 mg | AZD5672 150 mg, oral tablets, once daily, double-blinded |
| BG004 | Placebo | Placebo to AZD5672, oral tablets, once daily, double-blinded |
| BG005 | Etanercept | Etanercept 50 mg, subcutaneous injection, once weekly, open-label |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Year |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Duration of rheumatoid arthritis | Number | participants |
| ||||||||||||||||
| Disease Activity Score (based on 28 joint counts) (DAS28) | Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of disease activity; and ESR) after 12 Weeks' treatment. A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms. | Mean | Standard Deviation | Units on a scale |
|
| 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 | American College of Rheumatology 20 Response (ACR20) | The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 12 Weeks' treatment. | Posted | Number | Participants | 12 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | American College of Rheumatology 50 Response (ACR50) | The number of participants with greater to or equal to 50% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 12 Weeks' treatment. | Posted | Number | Participants | 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | American College of Rheumatology 70 Response (ACR70) | The number of participants with greater to or equal to 70% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 12 Weeks' treatment. | Posted | Number | Participants | 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Activity Score (Based on 28 Joint Count) (DAS28) | Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of disease activity; and ESR) after 12 Weeks' treatment. A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 12 Weeks |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Health Assessment Questionnaire - Disability Index (HAQ-DI) | Change from baseline in HAQ-DI (a measure of patients assessment of physical function scored between zero and 3) after 6 months' treatment, calculated as score at 12 Weeks minus score at baseline. A change of zero indicates no effect of treatment and a negative change of 0.22 or greater indicates an improvement in symptoms. The HAQ-DI scale runs from 0 to 3, with higher scores indicating greater disability. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 12 Weeks |
|
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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 | AZD5672 20 mg | AZD5672 20 mg, oral tablets, once daily, double-blinded | 0 | 52 | 12 | 52 | ||
| EG001 | AZD5672 50 mg | AZD5672 50 mg, oral tablets, once daily, double-blinded | 1 | 52 | 11 | 52 | ||
| EG002 | AZD5672 100 mg | AZD5672 100 mg, oral tablets, once daily, double-blinded | 2 | 51 | 15 | 51 | ||
| EG003 | AZD5672 150 mg | AZD5672 150 mg, oral tablets, once daily, double-blinded | 2 | 76 | 21 | 76 | ||
| EG004 | Placebo | Placebo to AZD5672, oral tablets, once daily, double-blinded | 1 | 65 | 15 | 65 | ||
| EG005 | Etanercept | Etanercept 50 mg, subcutaneous injection, once weekly, open-label | 0 | 75 | 16 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatitis Cholestatic | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Polymyositis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
Hybrid ACR, ACRn, individual ACR components, Erythrocyte sedimentation rate (ESR), Short-form-36 (SF-36), Rheumatoid Arthritis Quality of Life (RAQoL) and Patient Insight Questionnaire (PIQ) did not provide extra information so are not presented
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | ClinicalTrialTransparency@astrazeneca.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 |
|---|---|
| C553747 | N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide |
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| 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 |
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| Male |
|
| Duration of rheumatoid arthritis <= 5years |
|
Placebo to AZD5672, oral tablets, once daily, double-blinded
| OG005 | Etanercept | Etanercept 50 mg, subcutaneous injection, once weekly, open-label |
|
|
Placebo to AZD5672, oral tablets, once daily, double-blinded
| OG005 | Etanercept | Etanercept 50 mg, subcutaneous injection, once weekly, open-label |
|
|
| Placebo |
Placebo to AZD5672, oral tablets, once daily, double-blinded |
| OG005 | Etanercept | Etanercept 50 mg, subcutaneous injection, once weekly, open-label |
|
|
| Placebo |
Placebo to AZD5672, oral tablets, once daily, double-blinded |
| OG005 | Etanercept | Etanercept 50 mg, subcutaneous injection, once weekly, open-label |
|
|