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This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.
A multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The on-treatment period is 4 weeks with weekly visits to the clinic, followed by a 4-week safety follow-up period after the last dose of ACP-196/placebo. The study was to evaluate the safety, PK, PD, and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACP-196 + Methotrexate | Experimental | Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week |
|
| Placebo + Methotrexate | Placebo Comparator | Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acalabrutinib | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score 28-CRP (DAS28-CRP) at Week 4 | Disease activity score 28 - C-reactive protein (DAS28-CRP) is a score to measure disease activity in patients with rheumatoid arthritis by aggregating data of 28 joints, and is calculated by the scores on scale using the following variables: The number of swollen and tender joints, CRP level, and patient's global assessment of disease activity. The total score of the DAS28 values may range from 2.0 to 10.0 while higher values mean a higher disease activity. | 4 weeks |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Acerta Clinical Trials | Acerta Pharma, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | United States | ||
| Achieve Clinical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | ACP-196 + Methotrexate | Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week |
| FG001 | Placebo + Methotrexate | Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
|
| Birmingham |
| Alabama |
| 35216 |
| United States |
| Advanced Arthritis Care and Research | Scottsdale | Arizona | 85258 | United States |
| TriWest Research Associates, LLC | El Cajon | California | 92020 | United States |
| Neuropsychiatric Research Center of Orange County | Orange | California | 92868 | United States |
| Pacific Arthritis Center Medical Group | Santa Monica | California | 93454 | United States |
| Inland Rheumatology and Osteoporosis Medical Group, Inc | Upland | California | 91786 | United States |
| San Marcus Research Clinic, Inc. | Hialeah | Florida | 33015 | United States |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | United States |
| Suncoast Clinical Research | New Port Richey | Florida | 34652 | United States |
| The Arthritis Center | Palm Harbor | Florida | 34684-3176 | United States |
| Office of George Timothy Kelly, MD | Las Vegas | Nevada | 89128 | United States |
| PMG Research of Salisbury | Salisbury | North Carolina | 28144 | United States |
| Health Research of Oklahoma | Oklahoma City | Oklahoma | 73103-2433 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Ramesh C. Gupta, MD | Memphis | Tennessee | 38119 | United States |
| Clear Lake Regional Medical Center | Webster | Texas | 77598 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat population, which included all randomized subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | ACP-196 + Methotrexate | Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week |
| BG001 | Placebo + Methotrexate | Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| DAS28-CRP at baseline | Using the scores on the scale, measure disease activity score from the DAS28 scale and results from the C-reactive protein at baseline. | Mean | Standard Deviation | Scores on Scale |
| ||||||||||||||||
| Duration of rheumatoid arthritis since initial diagnosis | To measure duration of rheumatoid arthritis since initial diagnosis at baseline | Mean | Standard Deviation | years |
| ||||||||||||||||
| Methotrexate dosing at baseline | To measure methotrexate exposure at baseline | Mean | Standard Deviation | mg/week |
|
| 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 28-CRP (DAS28-CRP) at Week 4 | Disease activity score 28 - C-reactive protein (DAS28-CRP) is a score to measure disease activity in patients with rheumatoid arthritis by aggregating data of 28 joints, and is calculated by the scores on scale using the following variables: The number of swollen and tender joints, CRP level, and patient's global assessment of disease activity. The total score of the DAS28 values may range from 2.0 to 10.0 while higher values mean a higher disease activity. | Intent-to-treat population, which included all randomized subjects | Posted | Mean | Standard Deviation | Scores on scale | 4 weeks |
|
|
|
From the date of the first dose of study drug up to 30 days after the date of the last dose of study drug, up to 6 months.
Subjects with multiple events for a given system organ class (SOC) and preferred term (PT) were counted only once for each SOC and PT. If the same event term was reported more than once for a subject, only the event with the highest grade was included.
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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 | ACP-196 + Methotrexate | Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week | 0 | 16 | 0 | 16 | 10 | 16 |
| EG001 | Placebo + Methotrexate | Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week | 0 | 15 | 0 | 15 | 6 | 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Full Blood Count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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Site and PI can publish/publicly present the results of the study only with prior written consent of Sponsor or otherwise after expiry of 12 months following completion of the study. Site and PI agree to provide 45 days written notice to Sponsor prior to submission for publication or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Hamdy, MD, VP of Early Development | Acerta Pharma | 650-591-2800 | 145 | a.hamdy@acerta-pharma.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 |
|---|---|
| C000604908 | acalabrutinib |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| 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 |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|