An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis
NCT ID: NCT00383188
Last Updated: 2021-08-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
305 participants
INTERVENTIONAL
2006-12-15
2008-07-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis
NCT00303563
A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy
NCT00316771
COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis
NCT00113308
A Study To Evaluate The Safety And Pharmacokinetic Profile Of A P38 Inhibitor (PH-797804) In Subjects With Rheumatoid Arthritis Who Are Also Taking Methotrexate
NCT00620685
INCB047986 in Rheumatoid Arthritis
NCT02151474
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
placebo
Capsule, once daily (QD) for 12 weeks
2
PH-797804
Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks
3
PH-797804
Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks
4
PH-797804
Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks
5
PH-797804
Capsule, 10 mg of PH-797804, once daily (QD) for 12 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
placebo
Capsule, once daily (QD) for 12 weeks
PH-797804
Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks
PH-797804
Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks
PH-797804
Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks
PH-797804
Capsule, 10 mg of PH-797804, once daily (QD) for 12 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
19 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Emeritus Research
Malvern East, Victoria, Australia
Centro de Estudos em Terapias Inovadoras
Curitiba, Paraná, Brazil
Hospital de Clínicas da UFPR
Curitiba, Paraná, Brazil
Escola Paulista de Medicina - EPM
São Paulo, São Paulo, Brazil
Hospital Heliópolis - PAM
São Paulo, São Paulo, Brazil
Hospital Gustavo Fricke
Viña del Mar, Región de Valparaíso, Chile
Hospital Regional de Rancagua
Rancagua, Región del Libertador General Bernardo O’Higgins, Chile
Hospital del Salvador
Santiago, RM, Chile
Office of Dr. Pedro Miranda
Santiago, RM, Chile
Hospital Clínica San Borja Arriarán
Santiago, RM, Chile
Fakultni nemocnice u sv. Anny v Brne
Brno, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
NZZ Bormed, s.r.o.
Ostrava - Trebovice, , Czechia
Revmatologicky ustav
Prague, , Czechia
Fakultni Thomayerova nemocnice s poliklinikou
Prague, , Czechia
PV-Medical s.r.o.
Zlín, , Czechia
East Tallinn Central Hospital
Tallinn, , Estonia
North Estonia Regional Hospital
Tallinn, , Estonia
Department of Rheumatology, CARE Hospital
Hyderabad, Andhra Pradesh, India
Nizam's Institute of Medical Sciences, Department of Rheumatology
Hyderabad, Andhra Pradesh, India
St. John's Medical College Hospital, Department of Orthopedics
Bangalore, Karnataka, India
T. N. Medical College and B. Y. L. Nair Ch. HospitalDepartment of Medicine and Rheumatology Clinic
Mumbai, Maharashtra, India
Dayanand Medical College and Hospital, Department of Orthopedics
Ludhiana, Punjab, India
Kovai Medical Center and Hospital,
Coimbatore, Tamil Nadu, India
Instituto Peruano del Hueso y la Articulación SAC.
Lima, , Peru
Instituto Peruano del Climaterio
Lima, , Peru
Instituto de Ginecologia y Reproduccion
Lima, , Peru
SP ZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego
Bialystok, , Poland
Centrum Osteoporozy i Chorob Kostno-Stawowych
Bialystok, , Poland
Poznanski Osrodek Medyczny
Poznan, , Poland
Centrum Badan Klinicznych
Warsaw, , Poland
City Hospital #4, Department of Therapy of Moscow Faculty of Russian State Medical University
Moscow, , Russia
Clinical Hospital #7
Moscow, , Russia
City Hospital # 28 "Maximilianovskaya"
Saint Petersburg, , Russia
St. Petersburg Clnical Hospital n.a. Sokolov (MSCh #122)
Saint Petersburg, , Russia
Smolensk State Medical Academy
Smolensk, , Russia
Office Of Dr. F. Le Clus
Johannesburg, Gauteng, South Africa
Dr S Sankovic
Parktown, Johannesburg, South Africa
Quinta-Med
Bloemfontein, , South Africa
St Augustines Medical Ctr 2
Durban, , South Africa
Clinresco Centres (Pty) Ltd
Kempton Park, , South Africa
Intercare Medical and Dental Centre
Pretoria, , South Africa
Hallym University Sacred Heart Hospital/Rheumatology, Internal Medicine
Anyang, , South Korea
Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine
Seoul, , South Korea
Hanyang University Hospital, Department of Rheumatology
Seoul, , South Korea
The Catholic University of Korea, Kangnam St. Mary's Hospital/ Rheumatology, Internal Medicine
Seoul, , South Korea
Hospital de Cruces
Barakaldo, Vizcaya, Spain
Hospital Nuestra Señora de Valme
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2006-003577-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RA POC
Identifier Type: OTHER
Identifier Source: secondary_id
A6631007
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.