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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003577-27 | EudraCT Number | ||
| RA POC | Other Identifier | Alias Study Number |
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Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
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| 5 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Capsule, once daily (QD) for 12 weeks |
| |
| PH-797804 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Week 12 | ACR20 responders: participants with greater than or equal to(>=)20% improvement in tender and swollen 28-joint counts from baseline, >=20% improvement in at least 3 of 5 measures: Patient's global assessment of arthritis(PGA), physician's global assessment of arthritis, participant's assessment of pain on visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI), C-reactive protein (CRP) in mg/liter (mg/L). PGA:participant assess overall disease activity on VAS, score:0(no arthritis) to 100(extreme arthritis), high score=more arthritis. Physician's global assessment:physician judge participant's overall disease activity on VAS, score:0(no arthritis) to 100millimeter(mm) (extreme arthritis), high score=more arthritis. Pain-VAS:participant assess arthritis pain on 100mm VAS, score:0mm (no pain) to 100mm (extreme pain), high score=more pain. HAQ-DI:functional disability evaluation, score:0 (no difficulty) to 3 (unable to do), high score=more disability. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Weeks 1, 2, 4, 8 and 16 | ACR20 responders: participants with greater than or equal to(>=)20% improvement in tender and swollen 28-joint counts from baseline, >=20% improvement in at least 3 of 5 measures: Patient's global assessment of arthritis(PGA), physician's global assessment of arthritis, participant's assessment of pain on visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI), C-reactive protein (CRP) in mg/L. PGA:participant assess overall disease activity on VAS, score:0(no arthritis) to 100(extreme arthritis), high score=more arthritis. Physician's global assessment:physician judge participant's overall disease activity on VAS, score:0(no arthritis) to 100millimeter(mm) (extreme arthritis), high score=more arthritis. Pain-VAS:participant assessed arthritis pain on 100mm VAS, score:0mm (no pain) to 100mm (extreme pain), high score=more pain. HAQ-DI:functional disability evaluation, score:0 (no difficulty) to 3 (unable to do), high score=more disability. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emeritus Research | Malvern East | Victoria | 3145 | Australia | ||
| Centro de Estudos em Terapias Inovadoras |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | PH-797804, 0.5 mg | Participants received PH-797804, 0.5 milligram (mg) capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| FG001 | PH79804, 3 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks |
|
| PH-797804 | Drug | Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks |
|
| PH-797804 | Drug | Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks |
|
| PH-797804 | Drug | Capsule, 10 mg of PH-797804, once daily (QD) for 12 weeks |
|
| Weeks 1, 2, 4, 8, 16 |
| Percentage of Participants Achieving American College of Rheumatology 50 Percent (%) (ACR 50) Response at Weeks 1, 2, 4, 8, 12 and 16 | ACR50 responders: participants with >= 50% improvement in tender and swollen 28-joint counts from baseline and >= 50% improvement in at least 3 of the 5 measures: PGA, physician global assessment, Pain-VAS, HAQ-DI and C-reactive protein (in mg/L). PGA: participant assessed overall disease activity on VAS, score: 0 (no arthritis) to 100 (extreme arthritis), higher score=more arthritis. Physician global assessment: physician judged participant's overall disease activity on VAS, score: 0 (no arthritis) to 100 mm VAS (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability. | Weeks 1, 2, 4, 8, 12 and 16 |
| Percentage of Participants Achieving American College of Rheumatology 70 Percent (%) (ACR 70) Response at Weeks 1, 2, 4, 8, 12 and 16 | ACR70 responders: participants with >=70% improvement in tender and swollen 28-joint counts from baseline and >= 70% improvement in at least 3 of the 5 measures: PGA, physician global assessment, Pain-VAS, HAQ-DI and CRP (in mg/L). PGA: participant assessed overall disease activity on VAS, score: 0 (no arthritis) to 100 (extreme arthritis), higher score=more arthritis. Physician global assessment: physician judged participant's overall disease activity on VAS, score: 0 (no arthritis) to 100 mm VAS (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability. | Weeks 1, 2, 4, 8, 12 and 16 |
| Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, 12 and 16 | A total of 28 tender/painful joints were assessed for tenderness or pain. The 28 joints included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees. Artificial joints were not assessed. | Baseline, Weeks 1, 2, 4, 8, 12 and 16 |
| Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, 12 and 16 | A total of 28 swollen joints were assessed. The 28 joints included: shoulders, elbows, wrists, MCP joints, PIP joints, and knees. Artificial joints were not assessed. | Baseline, Weeks 1, 2, 4, 8, 12 and 16 |
| Change From Baseline in Participant Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, 12 and 16 | Participants self-assessed the severity of arthritis pain using a 100 mm VAS between 0 mm (no pain) and 100 mm (most severe pain), where higher scores indicate higher degree of pain intensity. | Baseline, Weeks 1, 2, 4, 8, 12 and 16 |
| Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Weeks 1, 2, 4, 8 12 and 16 | Participants responded to the question "Considering all the ways your arthritis affects you, how are you feeling today?" was recorded using a 0-100 mm VAS where 0 mm (very well) and 100 mm (very poor). Higher scores indicated worse condition. | Baseline, Week 1, 2, 4, 8, 12 and 16 |
| Change From Baseline in Physician Global Assessment of Arthritis at Weeks 1, 2, 4, 8, 12 and 16 | Physician assessed the overall impact of arthritis on the participants' daily life based on the disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS between 0 mm (very good) and 100 mm (very poor). Higher scores indicating worse condition of arthritis. | Baseline, Week 1, 2, 4, 8, 12 and 16 |
| Change From Baseline in C-Reactive Protein (CRP) at Weeks 1, 2, 4, 8, 12 and 16 | C-reactive protein is a biochemical measure of inflammation and disease activity. | Baseline, Week 1, 2, 4, 8, 12 and 16 |
| Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4 [CRP]) at Weeks 1, 2, 4, 8, 12 and 16 | DAS28-4 (CRP) was calculated from 28-tender joint count and 28-swollen joint count, C-reactive protein (mg/L) and PGA : participant assessed overall disease activity on VAS, score:0(no arthritis) to 100(extreme arthritis). DAS28-4 (CRP) lower than (<) 3.2 implied mild disease activity, 3.2 to 5.1 implied moderate disease activity and greater than (>) 5.1 severe disease activity. Total score range: 0 to 9.4, higher score indicated more disease activity. | Baseline, Weeks 1, 2, 4, 8, 12 and 16 |
| Number of Participants Who Withdrew From Study Due to Lack of Efficacy | Baseline up to Week 16 |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 1, 2, 4, 8, 12 and 16 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing/grooming, arising, eating, walking, reaching, gripping, hygiene, and "other common activities" over past week. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total average possible score range 0 (least difficulty) to 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities. | Baseline, Week 1, 2, 4, 8, 12 and 16 |
| Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12 | The modified brief pain inventory-short form (mBPI-SF) is a pain assessment tool used to measure both pain intensity and pain interference using an 11-point numeric rating scale. Participants rated their pain severity, using a scale from 0 (no pain) to 10 (pain as bad as you can imagine), where higher scores indicate greater intensity of pain. Participants also rated the level of pain interference using a scale from 0 (no interference) to 10 (complete interference), where higher scores indicate more degree of interference in general daily activities. | Baseline, Week 1, 2, 4, 8 and 12 |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2 at Weeks 4 and 12 | The SF-36 version 2 is a 36-item generic health status measure standardized survey is a standardized survey evaluating 8 domains of functional health and well-being: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH). The summary score of these concepts is summarized as Physical component summary (PCS) score and Mental component summary (MCS) score, are based on a normalized sum of the 8 scale scores PF, RP, BP, GH, VT, SF, RE, and MH. The score for each of 8 domains were scaled from 0 (lowest level of functioning) to100 (highest level of functioning, where higher scores represented better level of functioning. 8 domains were summarized as 2 summary scores; PCS and MCS. Score range for each of the 2 summary scores = 0 (lowest level of functioning) to 100 (highest level of functioning), where higher scores represented better level of functioning. | Baseline, Weeks 4, 12 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events are events between first dose of study drug and up to week 16 after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. | Baseline up to Week 16 |
| Number of Participants With Laboratory Abnormalities | Haemoglobin, haematocrit, red blood cell count less than(<) 0.8*lower limit of normal [LLN], platelets <0.5*LLN and (&) greater than(>) 1.75*ULN, white blood cell count <0.6*LLN&>1.5x ULN, lymphocytes <0.8*LLN&>1.2*ULN, total neutrophils <0.8*LLN&>1.2*ULN, basophils, eosinophils, monocytes >1.2*ULN; total bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase >3.0*ULN, total protein <0.8*LLN&>1.2*ULN, albumin <0.8*LLN&>1.2*ULN; blood urea nitrogen, Creatinine, Uric Acid >1.2*ULN; Cholesterol >1.3*ULN, HDL Cholesterol <0.8*LLN, LDL Cholesterol >1.2*ULN, Triglycerides >1.3*ULN; Electrolytes: sodium <0.95*LLN&>1.05*ULN, potassium <0.9*LLN&>1.1*ULN, chloride, calcium, magnesium, bicarbonate <0.9*LLN&>1.1*ULN, phosphate <0.8*LLN&>1.2x ULN; glucose <0.6*LLN&>1.5*ULN, human chorionic gonadotrophin >0; CRP >1.25*ULN, ([urine-RBC, WBC, epithelial cells, crystals, yeast cells] >=6), urine casts >1, urine Bacteria >20. | Baseline up to Week 16 |
| Number of Participants With Clinically Significant Vital Signs Abnormalities | Pre-defined criteria for vital sign abnormalities: Maximum (max) increase from baseline in supine systolic blood pressure (SBP) >=30 milliliters of mercury (mmHg), maximum increase from baseline in supine diastolic blood pressure (DBP) >=20 mmHg. | Baseline up to Week 16 |
| Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters | 12-lead ECG were performed after the participant had rested quietly for at least 10 minutes in a supine position. ECG parameters included RR interval, PR interval, QRS complex, QT interval, corrected QT (QTc) interval, Bazett's correction QT (QTcB) interval, Heart Rate and Fridericia's correction (QTcF) interval. Clinical significance of 12-Lead ECG was judged by investigator. | Baseline up to Week 16 |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | Criteria for ECG abnormalities: maximum QT interval (millisecond [msec]): < 450, 450 to <480, 480 to <500, >= 500; maximum QT interval with Bazett's correction (QTcB interval) (msec): <450, 450 to <480, 480 to <500, >=500; maximum QT interval with Fridericia's correction (QTcF interval) (msec): <450, 450 to <480, 480 to <500, >=500; maximum QTc interval increase from baseline (msec): change <30, 30 <=change <60, change >=60. | Baseline up to Week 16 |
| Number of Participants With Clinically Significant Physical Examination Abnormalities | Following criteria and body systems were examined to identify the clinically significant physical examination abnormalities; general appearance, skin (presence of rash), head, ears, eyes, nose, and throat, lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs, peripheral edema), abdominal (palpation and auscultation), neurologic (mental status, station, gait, reflexes, motor and sensory function, coordination). Physical examination abnormalities were as determined by the investigator. | Baseline up to Week 16 |
| Minimum Observed Plasma Pre-dose Concentration (Ctrough Min) of Steady State | Predose |
| Number of Participants With Concomitant Medications | Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary. | Baseline up to Week 16 |
| Curitiba |
| Paraná |
| 80060-240 |
| Brazil |
| Hospital de Clínicas da UFPR | Curitiba | Paraná | 80060-900 | Brazil |
| Escola Paulista de Medicina - EPM | São Paulo | São Paulo | 04026-000 | Brazil |
| Hospital Heliópolis - PAM | São Paulo | São Paulo | 04230-000 | Brazil |
| Hospital Regional de Rancagua | Rancagua | Región del Libertador General Bernardo O’Higgins | Chile |
| Hospital del Salvador | Santiago | RM | 7500922 | Chile |
| Office of Dr. Pedro Miranda | Santiago | RM | 8331030 | Chile |
| Hospital Clínica San Borja Arriarán | Santiago | RM | 8360156 | Chile |
| Hospital Gustavo Fricke | Viña del Mar | Valparaiso | 2570017 | Chile |
| Fakultni nemocnice u sv. Anny v Brne | Brno | 656 91 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| NZZ Bormed, s.r.o. | Ostrava - Trebovice | 722 00 | Czechia |
| Revmatologicky ustav | Prague | 128 50 | Czechia |
| Fakultni Thomayerova nemocnice s poliklinikou | Prague | 140 59 | Czechia |
| PV-Medical s.r.o. | Zlín | 760 01 | Czechia |
| East Tallinn Central Hospital | Tallinn | 11312 | Estonia |
| North Estonia Regional Hospital | Tallinn | 13419 | Estonia |
| Department of Rheumatology, CARE Hospital | Hyderabad | Andhra Pradesh | 500 034 | India |
| Nizam's Institute of Medical Sciences, Department of Rheumatology | Hyderabad | Andhra Pradesh | 500 082 | India |
| St. John's Medical College Hospital, Department of Orthopedics | Bangalore | Karnataka | 560 034 | India |
| T. N. Medical College and B. Y. L. Nair Ch. HospitalDepartment of Medicine and Rheumatology Clinic | Mumbai | Maharashtra | 400 008 | India |
| Dayanand Medical College and Hospital, Department of Orthopedics | Ludhiana | Punjab | 141001 | India |
| Kovai Medical Center and Hospital, | Coimbatore | Tamil Nadu | 641 014 | India |
| Instituto Peruano del Hueso y la Articulación SAC. | Lima | L-27 | Peru |
| Instituto Peruano del Climaterio | Lima | L27 | Peru |
| Instituto de Ginecologia y Reproduccion | Lima | L33 | Peru |
| SP ZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego | Bialystok | 15-950 | Poland |
| Centrum Osteoporozy i Chorob Kostno-Stawowych | Bialystok | 16-461 | Poland |
| Poznanski Osrodek Medyczny | Poznan | 60-773 | Poland |
| Centrum Badan Klinicznych | Warsaw | 02-256 | Poland |
| City Hospital #4, Department of Therapy of Moscow Faculty of Russian State Medical University | Moscow | 115093 | Russia |
| Clinical Hospital #7 | Moscow | 115446 | Russia |
| City Hospital # 28 "Maximilianovskaya" | Saint Petersburg | 190000 | Russia |
| St. Petersburg Clnical Hospital n.a. Sokolov (MSCh #122) | Saint Petersburg | 194291 | Russia |
| Smolensk State Medical Academy | Smolensk | 214019 | Russia |
| Office Of Dr. F. Le Clus | Johannesburg | Gauteng | 1619 | South Africa |
| Dr S Sankovic | Parktown | Johannesburg | 2193 | South Africa |
| Quinta-Med | Bloemfontein | 9317 | South Africa |
| St Augustines Medical Ctr 2 | Durban | 4001 | South Africa |
| Clinresco Centres (Pty) Ltd | Kempton Park | South Africa |
| Intercare Medical and Dental Centre | Pretoria | 0081 | South Africa |
| Hallym University Sacred Heart Hospital/Rheumatology, Internal Medicine | Anyang | 431-070 | South Korea |
| Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine | Seoul | 120-752 | South Korea |
| Hanyang University Hospital, Department of Rheumatology | Seoul | 133-792 | South Korea |
| The Catholic University of Korea, Kangnam St. Mary's Hospital/ Rheumatology, Internal Medicine | Seoul | South Korea |
| Hospital de Cruces | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital Nuestra Señora de Valme | Seville | 41014 | Spain |
Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| FG002 | PH-797804, 6 mg | Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| FG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| FG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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The full analysis set (FAS) included all participants randomized to treatment and who had taken at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | PH-797804, 0.5 mg | Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| BG001 | PH79804, 3 mg | Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| BG002 | PH-797804, 6 mg | Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| BG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| BG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| 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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| Sex: Female, Male | Count of Participants | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Week 12 | ACR20 responders: participants with greater than or equal to(>=)20% improvement in tender and swollen 28-joint counts from baseline, >=20% improvement in at least 3 of 5 measures: Patient's global assessment of arthritis(PGA), physician's global assessment of arthritis, participant's assessment of pain on visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI), C-reactive protein (CRP) in mg/liter (mg/L). PGA:participant assess overall disease activity on VAS, score:0(no arthritis) to 100(extreme arthritis), high score=more arthritis. Physician's global assessment:physician judge participant's overall disease activity on VAS, score:0(no arthritis) to 100millimeter(mm) (extreme arthritis), high score=more arthritis. Pain-VAS:participant assess arthritis pain on 100mm VAS, score:0mm (no pain) to 100mm (extreme pain), high score=more pain. HAQ-DI:functional disability evaluation, score:0 (no difficulty) to 3 (unable to do), high score=more disability. | FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. Here 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. Missing values were imputed using last observation carried forward (LOCF). | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Weeks 1, 2, 4, 8 and 16 | ACR20 responders: participants with greater than or equal to(>=)20% improvement in tender and swollen 28-joint counts from baseline, >=20% improvement in at least 3 of 5 measures: Patient's global assessment of arthritis(PGA), physician's global assessment of arthritis, participant's assessment of pain on visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI), C-reactive protein (CRP) in mg/L. PGA:participant assess overall disease activity on VAS, score:0(no arthritis) to 100(extreme arthritis), high score=more arthritis. Physician's global assessment:physician judge participant's overall disease activity on VAS, score:0(no arthritis) to 100millimeter(mm) (extreme arthritis), high score=more arthritis. Pain-VAS:participant assessed arthritis pain on 100mm VAS, score:0mm (no pain) to 100mm (extreme pain), high score=more pain. HAQ-DI:functional disability evaluation, score:0 (no difficulty) to 3 (unable to do), high score=more disability. | FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. Missing values were imputed using LOCF except for Week 16. | Posted | Number | percentage of participants | Weeks 1, 2, 4, 8, 16 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology 50 Percent (%) (ACR 50) Response at Weeks 1, 2, 4, 8, 12 and 16 | ACR50 responders: participants with >= 50% improvement in tender and swollen 28-joint counts from baseline and >= 50% improvement in at least 3 of the 5 measures: PGA, physician global assessment, Pain-VAS, HAQ-DI and C-reactive protein (in mg/L). PGA: participant assessed overall disease activity on VAS, score: 0 (no arthritis) to 100 (extreme arthritis), higher score=more arthritis. Physician global assessment: physician judged participant's overall disease activity on VAS, score: 0 (no arthritis) to 100 mm VAS (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability. | FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. Missing values were imputed using LOCF except for Week 16. | Posted | Number | percentage of participants | Weeks 1, 2, 4, 8, 12 and 16 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology 70 Percent (%) (ACR 70) Response at Weeks 1, 2, 4, 8, 12 and 16 | ACR70 responders: participants with >=70% improvement in tender and swollen 28-joint counts from baseline and >= 70% improvement in at least 3 of the 5 measures: PGA, physician global assessment, Pain-VAS, HAQ-DI and CRP (in mg/L). PGA: participant assessed overall disease activity on VAS, score: 0 (no arthritis) to 100 (extreme arthritis), higher score=more arthritis. Physician global assessment: physician judged participant's overall disease activity on VAS, score: 0 (no arthritis) to 100 mm VAS (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability. | FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. Missing values were imputed using LOCF except for Week 16. | Posted | Number | percentage of participants | Weeks 1, 2, 4, 8, 12 and 16 |
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| Secondary | Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, 12 and 16 | A total of 28 tender/painful joints were assessed for tenderness or pain. The 28 joints included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees. Artificial joints were not assessed. | FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. Missing values were imputed using LOCF except for Week 16. | Posted | Least Squares Mean | Standard Error | Joint count | Baseline, Weeks 1, 2, 4, 8, 12 and 16 |
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| Secondary | Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, 12 and 16 | A total of 28 swollen joints were assessed. The 28 joints included: shoulders, elbows, wrists, MCP joints, PIP joints, and knees. Artificial joints were not assessed. | FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. Missing values were imputed using LOCF except for Week 16. | Posted | Least Squares Mean | Standard Error | Joint count | Baseline, Weeks 1, 2, 4, 8, 12 and 16 |
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| Secondary | Change From Baseline in Participant Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, 12 and 16 | Participants self-assessed the severity of arthritis pain using a 100 mm VAS between 0 mm (no pain) and 100 mm (most severe pain), where higher scores indicate higher degree of pain intensity. | FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. Missing values were imputed using LOCF except for Week 16. | Posted | Least Squares Mean | Standard Error | Millimeter (mm) | Baseline, Weeks 1, 2, 4, 8, 12 and 16 |
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| Secondary | Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Weeks 1, 2, 4, 8 12 and 16 | Participants responded to the question "Considering all the ways your arthritis affects you, how are you feeling today?" was recorded using a 0-100 mm VAS where 0 mm (very well) and 100 mm (very poor). Higher scores indicated worse condition. | FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. Missing values were imputed using LOCF except for Week 16. | Posted | Least Squares Mean | Standard Error | Millimeter (mm) | Baseline, Week 1, 2, 4, 8, 12 and 16 |
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| Secondary | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 1, 2, 4, 8, 12 and 16 | Physician assessed the overall impact of arthritis on the participants' daily life based on the disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS between 0 mm (very good) and 100 mm (very poor). Higher scores indicating worse condition of arthritis. | FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. Missing values were imputed using LOCF except for Week 16. | Posted | Least Squares Mean | Standard Error | Millimeter (mm) | Baseline, Week 1, 2, 4, 8, 12 and 16 |
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| Secondary | Change From Baseline in C-Reactive Protein (CRP) at Weeks 1, 2, 4, 8, 12 and 16 | C-reactive protein is a biochemical measure of inflammation and disease activity. | FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. Missing values were imputed using LOCF except for Week 16. | Posted | Least Squares Mean | Standard Error | milligram per liter (mg/L) | Baseline, Week 1, 2, 4, 8, 12 and 16 |
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| Secondary | Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4 [CRP]) at Weeks 1, 2, 4, 8, 12 and 16 | DAS28-4 (CRP) was calculated from 28-tender joint count and 28-swollen joint count, C-reactive protein (mg/L) and PGA : participant assessed overall disease activity on VAS, score:0(no arthritis) to 100(extreme arthritis). DAS28-4 (CRP) lower than (<) 3.2 implied mild disease activity, 3.2 to 5.1 implied moderate disease activity and greater than (>) 5.1 severe disease activity. Total score range: 0 to 9.4, higher score indicated more disease activity. | FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. Missing values were imputed using LOCF except for Week 16. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Weeks 1, 2, 4, 8, 12 and 16 |
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| Secondary | Number of Participants Who Withdrew From Study Due to Lack of Efficacy | FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to Week 16 |
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| Secondary | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 1, 2, 4, 8, 12 and 16 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing/grooming, arising, eating, walking, reaching, gripping, hygiene, and "other common activities" over past week. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total average possible score range 0 (least difficulty) to 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities. | FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. Missing values were imputed using LOCF except for Week 16. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 1, 2, 4, 8, 12 and 16 |
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| Secondary | Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12 | The modified brief pain inventory-short form (mBPI-SF) is a pain assessment tool used to measure both pain intensity and pain interference using an 11-point numeric rating scale. Participants rated their pain severity, using a scale from 0 (no pain) to 10 (pain as bad as you can imagine), where higher scores indicate greater intensity of pain. Participants also rated the level of pain interference using a scale from 0 (no interference) to 10 (complete interference), where higher scores indicate more degree of interference in general daily activities. | FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. Missing values were imputed using LOCF. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 1, 2, 4, 8 and 12 |
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| Secondary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2 at Weeks 4 and 12 | The SF-36 version 2 is a 36-item generic health status measure standardized survey is a standardized survey evaluating 8 domains of functional health and well-being: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH). The summary score of these concepts is summarized as Physical component summary (PCS) score and Mental component summary (MCS) score, are based on a normalized sum of the 8 scale scores PF, RP, BP, GH, VT, SF, RE, and MH. The score for each of 8 domains were scaled from 0 (lowest level of functioning) to100 (highest level of functioning, where higher scores represented better level of functioning. 8 domains were summarized as 2 summary scores; PCS and MCS. Score range for each of the 2 summary scores = 0 (lowest level of functioning) to 100 (highest level of functioning), where higher scores represented better level of functioning. | FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. Missing values were imputed using LOCF. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Weeks 4, 12 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events are events between first dose of study drug and up to week 16 after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. | Safety analysis set included all participants randomized to treatment who had taken at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Week 16 |
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| Secondary | Number of Participants With Laboratory Abnormalities | Haemoglobin, haematocrit, red blood cell count less than(<) 0.8*lower limit of normal [LLN], platelets <0.5*LLN and (&) greater than(>) 1.75*ULN, white blood cell count <0.6*LLN&>1.5x ULN, lymphocytes <0.8*LLN&>1.2*ULN, total neutrophils <0.8*LLN&>1.2*ULN, basophils, eosinophils, monocytes >1.2*ULN; total bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase >3.0*ULN, total protein <0.8*LLN&>1.2*ULN, albumin <0.8*LLN&>1.2*ULN; blood urea nitrogen, Creatinine, Uric Acid >1.2*ULN; Cholesterol >1.3*ULN, HDL Cholesterol <0.8*LLN, LDL Cholesterol >1.2*ULN, Triglycerides >1.3*ULN; Electrolytes: sodium <0.95*LLN&>1.05*ULN, potassium <0.9*LLN&>1.1*ULN, chloride, calcium, magnesium, bicarbonate <0.9*LLN&>1.1*ULN, phosphate <0.8*LLN&>1.2x ULN; glucose <0.6*LLN&>1.5*ULN, human chorionic gonadotrophin >0; CRP >1.25*ULN, ([urine-RBC, WBC, epithelial cells, crystals, yeast cells] >=6), urine casts >1, urine Bacteria >20. | Safety analysis set included all participants randomized to treatment who had taken at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Week 16 |
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| Secondary | Number of Participants With Clinically Significant Vital Signs Abnormalities | Pre-defined criteria for vital sign abnormalities: Maximum (max) increase from baseline in supine systolic blood pressure (SBP) >=30 milliliters of mercury (mmHg), maximum increase from baseline in supine diastolic blood pressure (DBP) >=20 mmHg. | Safety analysis set included all participants randomized to treatment who had taken at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Week 16 |
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| Secondary | Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters | 12-lead ECG were performed after the participant had rested quietly for at least 10 minutes in a supine position. ECG parameters included RR interval, PR interval, QRS complex, QT interval, corrected QT (QTc) interval, Bazett's correction QT (QTcB) interval, Heart Rate and Fridericia's correction (QTcF) interval. Clinical significance of 12-Lead ECG was judged by investigator. | FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to Week 16 |
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| Secondary | Number of Participants With Electrocardiogram (ECG) Abnormalities | Criteria for ECG abnormalities: maximum QT interval (millisecond [msec]): < 450, 450 to <480, 480 to <500, >= 500; maximum QT interval with Bazett's correction (QTcB interval) (msec): <450, 450 to <480, 480 to <500, >=500; maximum QT interval with Fridericia's correction (QTcF interval) (msec): <450, 450 to <480, 480 to <500, >=500; maximum QTc interval increase from baseline (msec): change <30, 30 <=change <60, change >=60. | Safety analysis set included all participants randomized to treatment who had taken at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Week 16 |
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| Secondary | Number of Participants With Clinically Significant Physical Examination Abnormalities | Following criteria and body systems were examined to identify the clinically significant physical examination abnormalities; general appearance, skin (presence of rash), head, ears, eyes, nose, and throat, lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs, peripheral edema), abdominal (palpation and auscultation), neurologic (mental status, station, gait, reflexes, motor and sensory function, coordination). Physical examination abnormalities were as determined by the investigator. | Safety analysis set included all participants randomized to treatment who had taken at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Week 16 |
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| Secondary | Minimum Observed Plasma Pre-dose Concentration (Ctrough Min) of Steady State | Analysis set included all participants randomized to treatment who had taken at least 1 dose of PH-797804. | Posted | Mean | Standard Deviation | Nanogram per milliliter | Predose |
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| Secondary | Number of Participants With Concomitant Medications | Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary. | Safety analysis set included all participants randomized to treatment who had taken at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Week 16 |
|
Baseline up to Week 16
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PH-797804, 0.5 mg | Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. | 2 | 69 | 38 | 69 | ||
| EG001 | PH79804, 3 mg | Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. | 3 | 74 | 45 | 74 | ||
| EG002 | PH-797804, 6 mg | Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. | 4 | 44 | 27 | 44 | ||
| EG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. | 5 | 40 | 32 | 40 | ||
| EG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. | 1 | 75 | 41 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cyclitis | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Electrocardiogram change | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Flatulance | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Mass | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Thirst | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Neurosis | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rheumatoid nodule | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Neutrophilia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Skin nodule | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Chloasma | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Palpable purpura | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vulvovaginitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vaginal candidiasis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cervical root pain | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Radiculitis | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Allergic pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Accelerated hypertension | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Episcleritis | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Corneal erosion | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Fractured ischium | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Electrocardiogram T wave inversion | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Electrocardiogram Q wave abnormal | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 11.0 | Non-systematic Assessment |
| |
| Leukocyturia | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C542398 | PH 797804 |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Difference in percentage |
| 10.81 |
| Standard Error of the Mean |
| 7.86 |
| 2-Sided |
| 95 |
| -4.602 |
| 26.224 |
| Superiority |
| Chi-squared | 0.2783 | Difference in percentage | 9.83 | Standard Error of the Mean | 9.16 | 2-Sided | 95 | -8.123 | 27.799 | Superiority |
| Chi-squared | 0.3381 | Difference in percentage | 8.92 | Standard Error of the Mean | 9.43 | 2-Sided | 95 | -9.566 | 27.404 | Superiority |
| OG001 | PH-797804, 3 mg | Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG002 | PH-797804, 6 mg | Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
|
| PH-797804, 3 mg |
Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG002 | PH-797804, 6 mg | Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
|
| PH-797804, 3 mg |
Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG002 | PH-797804, 6 mg | Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
|
Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
|
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
|
Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
|
Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
|
| PH-797804, 6 mg |
Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
|
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
|
| OG002 | PH-797804, 6 mg | Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
|
Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
| OG002 | PH-797804, 6 mg | Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
|
| OG002 | PH-797804, 6 mg | Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
|
| OG001 | PH-797804, 3 mg | Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG002 | PH-797804, 6 mg | Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
|
| OG002 | PH-797804, 6 mg | Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
| PH-797804, 3 mg |
Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG002 | PH-797804, 6 mg | Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
| PH-797804, 6 mg |
Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
|
|
| OG003 | PH-797804, 10 mg | Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
| OG004 | Placebo | Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks. |
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