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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_531 |
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The study will compare the effects of prednisone vs placebo on synovial blood flow and overall DAS (disease activity score) in patients with rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone 15 mg | Experimental | Prednisone 15 mg tablets once daily for 15 days |
|
| Placebo 15 mg | Placebo Comparator | Prednisone 15 mg placebo tablets once daily for 15 days |
|
| Prednisone 7.5 mg | Experimental | Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis. |
|
| Placebo 7.5 mg | Placebo Comparator | Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone 15 mg | Drug | Prednisone 15 mg tablets once daily for 15 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Synovial Blood Flow | Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow. | Baseline and Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP]) | The DAS28(CRP) is a measure of disease activity with components which include the tender joint count (TJC) & swollen joint count (SJC) (each out of 28 joints counted), a Global Health (GH) index (100 mm visual analog scale [VAS]), and the CRP (in mg/L measured from lab test). The scoring formula was: DAS28(CRP) = 0.56*SQR(TJC28) + 0.28*SQR(SJC28) + 0.36*ln(CRP+1) + 0.014*GH(VAS) + 0.96. Where SQR is square root and ln is natural log. The formula produces a score from 0 to 10: >5.1 means high disease activity; <3.2 means low disease activity, <2.6 is generally considered remission. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22972032 | Result | Seymour MW, Kelly S, Beals CR, Malice MP, Bolognese JA, Dardzinski BJ, Cheng AS, Cummings CE, Smugar SS, McClinton C, Fox A, Dooley WM, Pitzalis C, Taylor PC. Ultrasound of metacarpophalangeal joints is a sensitive and reliable endpoint for drug therapies in rheumatoid arthritis: results of a randomized, two-center placebo-controlled study. Arthritis Res Ther. 2012 Sep 12;14(5):R198. doi: 10.1186/ar4034. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prednisone 15 mg | Prednisone 15 mg tablets once daily for 15 days |
| FG001 | Placebo 15 mg | Prednisone 15 mg placebo tablets once daily for 15 days |
| FG002 | Prednisone 7.5 mg | Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis. |
| FG003 | Placebo 7.5 mg | Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prednisone 15 mg | Prednisone 15 mg tablets once daily for 15 days |
| BG001 | Placebo 15 mg | Prednisone 15 mg placebo tablets once daily for 15 days |
| 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 | Synovial Blood Flow | Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow. | Posted | Mean | Standard Deviation | pixel count | Baseline and Day 14 |
|
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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 | Prednisone 15 mg | Prednisone 15 mg tablets once daily for 15 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo Tablets | Drug | Prednisone placebo tablets once daily for 15 days. |
|
| Prednisone 7.5 mg | Drug | Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days |
|
|
| Placebo Over-Encapsulated Tablets | Drug | Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days |
|
| Baseline and Day 14 |
| BG002 | Prednisone 7.5 mg | Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis. |
| BG003 | Placebo 7.5 mg | Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Prednisone 15 mg placebo tablets once daily for 15 days |
| OG002 | Prednisone 7.5 mg | Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis. |
| OG003 | Placebo 7.5 mg | Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis. |
|
|
| Secondary | Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP]) | The DAS28(CRP) is a measure of disease activity with components which include the tender joint count (TJC) & swollen joint count (SJC) (each out of 28 joints counted), a Global Health (GH) index (100 mm visual analog scale [VAS]), and the CRP (in mg/L measured from lab test). The scoring formula was: DAS28(CRP) = 0.56*SQR(TJC28) + 0.28*SQR(SJC28) + 0.36*ln(CRP+1) + 0.014*GH(VAS) + 0.96. Where SQR is square root and ln is natural log. The formula produces a score from 0 to 10: >5.1 means high disease activity; <3.2 means low disease activity, <2.6 is generally considered remission. | Posted | Mean | Standard Deviation | score on scale | Baseline and Day 14 |
|
|
|
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | Placebo 15 mg | Prednisone 15 mg placebo tablets once daily for 15 days | 0 | 10 | 4 | 10 |
| EG002 | Prednisone 7.5 mg | Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis. | 0 | 18 | 6 | 18 |
| EG003 | Placebo 7.5 mg | Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis. | 1 | 9 | 2 | 9 |
| Irritable Bowel Syndrome | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Vulvovaginal Candidiasis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
|
| Arthalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Chronic Obstructive Pumonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Ingrowing Nail | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Day 14 |
|
| Change from Baseline at Day 14 |
|