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An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis

Primary Purpose

Arthritis, Rheumatoid

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

placebo

PH-797804

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Arthritis, Rheumatoid

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosed with RA and has failed at least 1 DMARD therapy

Exclusion Criteria:

Any other inflammatory arthritis and any significant history of acute or chronic infection with immunomodulatory etiology.

Sites / Locations

Emeritus Research
Centro de Estudos em Terapias Inovadoras
Hospital de Clínicas da UFPR
Escola Paulista de Medicina - EPM
Hospital Heliópolis - PAM
Hospital del Salvador
Office of Dr. Pedro Miranda
Hospital Clínica San Borja Arriarán
Hospital Gustavo Fricke
Hospital Regional de Rancagua
Fakultni nemocnice u sv. Anny v Brne
Fakultni nemocnice Olomouc
NZZ Bormed, s.r.o.
Revmatologicky ustav
Fakultni Thomayerova nemocnice s poliklinikou
PV-Medical s.r.o.
East Tallinn Central Hospital
North Estonia Regional Hospital
Department of Rheumatology, CARE Hospital
Nizam's Institute of Medical Sciences, Department of Rheumatology
St. John's Medical College Hospital, Department of Orthopedics
T. N. Medical College and B. Y. L. Nair Ch. HospitalDepartment of Medicine and Rheumatology Clinic
Dayanand Medical College and Hospital, Department of Orthopedics
Kovai Medical Center and Hospital,
Hallym University Sacred Heart Hospital/Rheumatology, Internal Medicine
Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine
Hanyang University Hospital, Department of Rheumatology
The Catholic University of Korea, Kangnam St. Mary's Hospital/ Rheumatology, Internal Medicine
Instituto Peruano del Hueso y la Articulación SAC.
Instituto Peruano del Climaterio
Instituto de Ginecologia y Reproduccion
SP ZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego
Centrum Osteoporozy i Chorob Kostno-Stawowych
Poznanski Osrodek Medyczny
Centrum Badan Klinicznych
City Hospital #4, Department of Therapy of Moscow Faculty of Russian State Medical University
Clinical Hospital #7
Smolensk State Medical Academy
City Hospital # 28 "Maximilianovskaya"
St. Petersburg Clnical Hospital n.a. Sokolov (MSCh #122)
Office Of Dr. F. Le Clus
Dr S Sankovic
Quinta-Med
St Augustines Medical Ctr 2
Clinresco Centres (Pty) Ltd
Intercare Medical and Dental Centre
Hospital de Cruces
Hospital Nuestra Señora de Valme

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Number of Participants Who Withdrew From Study Due to Lack of Efficacy

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.

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.

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.

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.

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.

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.

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.

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.

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.

Minimum Observed Plasma Pre-dose Concentration (Ctrough Min) of Steady State

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.

Full Information

NCT ID

NCT00383188

First Posted

September 28, 2006

Last Updated

July 26, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00383188

Brief Title

An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis

Official Title

A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH 797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

December 15, 2006 (Actual)

Primary Completion Date

July 1, 2008 (Actual)

Study Completion Date

July 16, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Rheumatoid

Keywords

Arthritis, Rheumatoid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

305 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Capsule, once daily (QD) for 12 weeks

Intervention Type

Drug

Intervention Name(s)

PH-797804

Intervention Description

Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks

Intervention Type

Drug

Intervention Name(s)

PH-797804

Intervention Description

Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks

Intervention Type

Drug

Intervention Name(s)

PH-797804

Intervention Description

Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks

Intervention Type

Drug

Intervention Name(s)

PH-797804

Intervention Description

Capsule, 10 mg of PH-797804, once daily (QD) for 12 weeks

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Week 12

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Weeks 1, 2, 4, 8 and 16

Description

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.

Time Frame

Weeks 1, 2, 4, 8, 16

Title

Percentage of Participants Achieving American College of Rheumatology 50 Percent (%) (ACR 50) Response at Weeks 1, 2, 4, 8, 12 and 16

Description

Time Frame

Weeks 1, 2, 4, 8, 12 and 16

Title

Percentage of Participants Achieving American College of Rheumatology 70 Percent (%) (ACR 70) Response at Weeks 1, 2, 4, 8, 12 and 16

Description

Time Frame

Weeks 1, 2, 4, 8, 12 and 16

Title

Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, 12 and 16

Description

Time Frame

Baseline, Weeks 1, 2, 4, 8, 12 and 16

Title

Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, 12 and 16

Description

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.

Time Frame

Baseline, Weeks 1, 2, 4, 8, 12 and 16

Title

Change From Baseline in Participant Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, 12 and 16

Description

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.

Time Frame

Baseline, Weeks 1, 2, 4, 8, 12 and 16

Title

Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Weeks 1, 2, 4, 8 12 and 16

Description

Time Frame

Baseline, Week 1, 2, 4, 8, 12 and 16

Title

Change From Baseline in Physician Global Assessment of Arthritis at Weeks 1, 2, 4, 8, 12 and 16

Description

Time Frame

Baseline, Week 1, 2, 4, 8, 12 and 16

Title

Change From Baseline in C-Reactive Protein (CRP) at Weeks 1, 2, 4, 8, 12 and 16

Description

C-reactive protein is a biochemical measure of inflammation and disease activity.

Time Frame

Baseline, Week 1, 2, 4, 8, 12 and 16

Title

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

Description

Time Frame

Baseline, Weeks 1, 2, 4, 8, 12 and 16

Title

Number of Participants Who Withdrew From Study Due to Lack of Efficacy

Time Frame

Baseline up to Week 16

Title

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 1, 2, 4, 8, 12 and 16

Description

Time Frame

Baseline, Week 1, 2, 4, 8, 12 and 16

Title

Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 1, 2, 4, 8 and 12

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2 at Weeks 4 and 12

Description

Time Frame

Baseline, Weeks 4, 12

Title

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

Baseline up to Week 16

Title

Number of Participants With Laboratory Abnormalities

Description

Time Frame

Baseline up to Week 16

Title

Number of Participants With Clinically Significant Vital Signs Abnormalities

Description

Time Frame

Baseline up to Week 16

Title

Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters

Description

Time Frame

Baseline up to Week 16

Title

Number of Participants With Electrocardiogram (ECG) Abnormalities

Description

Time Frame

Baseline up to Week 16

Title

Number of Participants With Clinically Significant Physical Examination Abnormalities

Description

Time Frame

Baseline up to Week 16

Title

Minimum Observed Plasma Pre-dose Concentration (Ctrough Min) of Steady State

Time Frame

Predose

Title

Number of Participants With Concomitant Medications

Description

Time Frame

Baseline up to Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosed with RA and has failed at least 1 DMARD therapy Exclusion Criteria: Any other inflammatory arthritis and any significant history of acute or chronic infection with immunomodulatory etiology.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Emeritus Research

City

Malvern East

State/Province

Victoria

ZIP/Postal Code

3145

Country

Australia

Facility Name

Centro de Estudos em Terapias Inovadoras

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

80060-240

Country

Brazil

Facility Name

Hospital de Clínicas da UFPR

City

Curitiba

State/Province

ZIP/Postal Code

80060-900

Country

Brazil

Facility Name

Escola Paulista de Medicina - EPM

City

São Paulo

State/Province

ZIP/Postal Code

04026-000

Country

Brazil

Facility Name

Hospital Heliópolis - PAM

City

São Paulo

State/Province

ZIP/Postal Code

04230-000

Country

Brazil

Facility Name

Hospital del Salvador

City

Santiago

State/Province

ZIP/Postal Code

7500922

Country

Chile

Facility Name

Office of Dr. Pedro Miranda

City

Santiago

State/Province

ZIP/Postal Code

8331030

Country

Chile

Facility Name

Hospital Clínica San Borja Arriarán

City

Santiago

State/Province

ZIP/Postal Code

8360156

Country

Chile

Facility Name

Hospital Gustavo Fricke

City

Viña Del Mar

State/Province

V Region

ZIP/Postal Code

2570017

Country

Chile

Facility Name

Hospital Regional de Rancagua

City

Rancagua

State/Province

VI Región

Country

Chile

Facility Name

Fakultni nemocnice u sv. Anny v Brne

City

Brno

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

Fakultni nemocnice Olomouc

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

NZZ Bormed, s.r.o.

City

Ostrava - Trebovice

ZIP/Postal Code

722 00

Country

Czechia

Facility Name

Revmatologicky ustav

City

Praha 2

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

Fakultni Thomayerova nemocnice s poliklinikou

City

Praha 4

ZIP/Postal Code

140 59

Country

Czechia

Facility Name

PV-Medical s.r.o.

City

Zlin

ZIP/Postal Code

760 01

Country

Czechia

Facility Name

East Tallinn Central Hospital

City

Tallinn

ZIP/Postal Code

11312

Country

Estonia

Facility Name

North Estonia Regional Hospital

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Department of Rheumatology, CARE Hospital

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500 034

Country

India

Facility Name

Nizam's Institute of Medical Sciences, Department of Rheumatology

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500 082

Country

India

Facility Name

St. John's Medical College Hospital, Department of Orthopedics

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560 034

Country

India

Facility Name

T. N. Medical College and B. Y. L. Nair Ch. HospitalDepartment of Medicine and Rheumatology Clinic

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400 008

Country

India

Facility Name

Dayanand Medical College and Hospital, Department of Orthopedics

City

Ludhiana

State/Province

Punjab

ZIP/Postal Code

141001

Country

India

Facility Name

Kovai Medical Center and Hospital,

City

Coimbatore

State/Province

Tamil NADU

ZIP/Postal Code

641 014

Country

India

Facility Name

Hallym University Sacred Heart Hospital/Rheumatology, Internal Medicine

City

Anyang

ZIP/Postal Code

431-070

Country

Korea, Republic of

Facility Name

Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Hanyang University Hospital, Department of Rheumatology

City

Seoul

ZIP/Postal Code

133-792

Country

Korea, Republic of

Facility Name

The Catholic University of Korea, Kangnam St. Mary's Hospital/ Rheumatology, Internal Medicine

City

Seoul

Country

Korea, Republic of

Facility Name

Instituto Peruano del Hueso y la Articulación SAC.

City

Lima

ZIP/Postal Code

L-27

Country

Peru

Facility Name

Instituto Peruano del Climaterio

City

Lima

ZIP/Postal Code

L27

Country

Peru

Facility Name

Instituto de Ginecologia y Reproduccion

City

Lima

ZIP/Postal Code

L33

Country

Peru

Facility Name

SP ZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego

City

Bialystok

ZIP/Postal Code

15-950

Country

Poland

Facility Name

Centrum Osteoporozy i Chorob Kostno-Stawowych

City

Bialystok

ZIP/Postal Code

16-461

Country

Poland

Facility Name

Poznanski Osrodek Medyczny

City

Poznan

ZIP/Postal Code

60-773

Country

Poland

Facility Name

Centrum Badan Klinicznych

City

Warszawa

ZIP/Postal Code

02-256

Country

Poland

Facility Name

City Hospital #4, Department of Therapy of Moscow Faculty of Russian State Medical University

City

Moscow

ZIP/Postal Code

115093

Country

Russian Federation

Facility Name

Clinical Hospital #7

City

Moscow

ZIP/Postal Code

115446

Country

Russian Federation

Facility Name

Smolensk State Medical Academy

City

Smolensk

ZIP/Postal Code

214019

Country

Russian Federation

Facility Name

City Hospital # 28 "Maximilianovskaya"

City

St. Petersburg

ZIP/Postal Code

190000

Country

Russian Federation

Facility Name

St. Petersburg Clnical Hospital n.a. Sokolov (MSCh #122)

City

St. Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Office Of Dr. F. Le Clus

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

1619

Country

South Africa

Facility Name

Dr S Sankovic

City

Parktown

State/Province

Johannesburg

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Quinta-Med

City

Bloemfontein

ZIP/Postal Code

9317

Country

South Africa

Facility Name

St Augustines Medical Ctr 2

City

Durban

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Clinresco Centres (Pty) Ltd

City

Kempton Park

Country

South Africa

Facility Name

Intercare Medical and Dental Centre

City

Pretoria

ZIP/Postal Code

0081

Country

South Africa

Facility Name

Hospital de Cruces

City

Barakaldo

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Hospital Nuestra Señora de Valme

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6631007&StudyName=An%20Oral%20p38%20Inhibitor%20Investigating%20Safety%2C%20Efficacy%2C%20And%20PK%20In%20Subjects%20With%20Active%20Rheumatoid%20Arthritis

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis

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