NCT00383188

Brief Summary

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2006

Geographic Reach
11 countries

46 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2008

Completed
13.1 years until next milestone

Results Posted

Study results publicly available

August 20, 2021

Completed
Last Updated

August 20, 2021

Status Verified

July 1, 2021

Enrollment Period

1.5 years

First QC Date

September 28, 2006

Results QC Date

July 26, 2021

Last Update Submit

July 26, 2021

Conditions

Arthritis, Rheumatoid

Keywords

ArthritisRheumatoid

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (22)

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

    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

    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

    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

    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

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

  • +17 more secondary outcomes

Study Arms (5)

1

PLACEBO COMPARATOR
Drug: placebo

2

EXPERIMENTAL
Drug: PH-797804

3

EXPERIMENTAL
Drug: PH-797804

4

EXPERIMENTAL
Drug: PH-797804

5

EXPERIMENTAL
Drug: PH-797804

Interventions

placeboDRUG

Capsule, once daily (QD) for 12 weeks

1
PH-797804DRUG

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

2

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with RA and has failed at least 1 DMARD therapy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (48)

Emeritus Research

Malvern East, Victoria, 3145, Australia

Location

Centro de Estudos em Terapias Inovadoras

Curitiba, Paraná, 80060-240, Brazil

Location

Hospital de Clínicas da UFPR

Curitiba, Paraná, 80060-900, Brazil

Location

Escola Paulista de Medicina - EPM

São Paulo, São Paulo, 04026-000, Brazil

Location

Hospital Heliópolis - PAM

São Paulo, São Paulo, 04230-000, Brazil

Location

Hospital Gustavo Fricke

Viña del Mar, Región de Valparaíso, 2570017, Chile

Location

Hospital Regional de Rancagua

Rancagua, Región del Libertador General Bernardo O’Higgins, Chile

Location

Hospital del Salvador

Santiago, RM, 7500922, Chile

Location

Office of Dr. Pedro Miranda

Santiago, RM, 8331030, Chile

Location

Hospital Clínica San Borja Arriarán

Santiago, RM, 8360156, Chile

Location

Fakultni nemocnice u sv. Anny v Brne

Brno, 656 91, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

NZZ Bormed, s.r.o.

Ostrava - Trebovice, 722 00, Czechia

Location

Revmatologicky ustav

Prague, 128 50, Czechia

Location

Fakultni Thomayerova nemocnice s poliklinikou

Prague, 140 59, Czechia

Location

PV-Medical s.r.o.

Zlín, 760 01, Czechia

Location

East Tallinn Central Hospital

Tallinn, 11312, Estonia

Location

North Estonia Regional Hospital

Tallinn, 13419, Estonia

Location

Department of Rheumatology, CARE Hospital

Hyderabad, Andhra Pradesh, 500 034, India

Location

Nizam's Institute of Medical Sciences, Department of Rheumatology

Hyderabad, Andhra Pradesh, 500 082, India

Location

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

Bangalore, Karnataka, 560 034, India

Location

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

Mumbai, Maharashtra, 400 008, India

Location

Dayanand Medical College and Hospital, Department of Orthopedics

Ludhiana, Punjab, 141001, India

Location

Kovai Medical Center and Hospital,

Coimbatore, Tamil Nadu, 641 014, India

Location

Instituto Peruano del Hueso y la Articulación SAC.

Lima, L-27, Peru

Location

Instituto Peruano del Climaterio

Lima, L27, Peru

Location

Instituto de Ginecologia y Reproduccion

Lima, L33, Peru

Location

SP ZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego

Bialystok, 15-950, Poland

Location

Centrum Osteoporozy i Chorob Kostno-Stawowych

Bialystok, 16-461, Poland

Location

Poznanski Osrodek Medyczny

Poznan, 60-773, Poland

Location

Centrum Badan Klinicznych

Warsaw, 02-256, Poland

Location

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

Moscow, 115093, Russia

Location

Clinical Hospital #7

Moscow, 115446, Russia

Location

City Hospital # 28 "Maximilianovskaya"

Saint Petersburg, 190000, Russia

Location

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

Saint Petersburg, 194291, Russia

Location

Smolensk State Medical Academy

Smolensk, 214019, Russia

Location

Office Of Dr. F. Le Clus

Johannesburg, Gauteng, 1619, South Africa

Location

Dr S Sankovic

Parktown, Johannesburg, 2193, South Africa

Location

Quinta-Med

Bloemfontein, 9317, South Africa

Location

St Augustines Medical Ctr 2

Durban, 4001, South Africa

Location

Clinresco Centres (Pty) Ltd

Kempton Park, South Africa

Location

Intercare Medical and Dental Centre

Pretoria, 0081, South Africa

Location

Hallym University Sacred Heart Hospital/Rheumatology, Internal Medicine

Anyang, 431-070, South Korea

Location

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

Seoul, 120-752, South Korea

Location

Hanyang University Hospital, Department of Rheumatology

Seoul, 133-792, South Korea

Location

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

Seoul, South Korea

Location

Hospital de Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital Nuestra Señora de Valme

Seville, 41014, Spain

Location

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Interventions

PH 797804

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2006

First Posted

October 2, 2006

Study Start

December 15, 2006

Primary Completion

July 1, 2008

Study Completion

July 16, 2008

Last Updated

August 20, 2021

Results First Posted

August 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

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.

More information

Locations

PL(4)CZ(6)ES(2)AU(1)IN(6)PE(3)KR(4)ZA(6)BR(4)RU(5)CL(5)