Clinical trial NCT00383188: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Keywords: Arthritis
Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-02
Enrollment: 305
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Weeks 1, 2, 4, 8 and 16
timeFrame: Weeks 1, 2, 4, 8, 16
measure: Percentage of Participants Achieving American College of Rheumatology 50 Percent (%) (ACR 50) Response at Weeks 1, 2, 4, 8, 12 and 16
timeFrame: Weeks 1, 2, 4, 8, 12 and 16
measure: Percentage of Participants Achieving American College of Rheumatology 70 Percent (%) (ACR 70) Response at Weeks 1, 2, 4, 8, 12 and 16
timeFrame: Weeks 1, 2, 4, 8, 12 and 16
measure: Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, 12 and 16
timeFrame: Baseline, Weeks 1, 2, 4, 8, 12 and 16
measure: Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, 12 and 16
timeFrame: Baseline, Weeks 1, 2, 4, 8, 12 and 16
measure: Change From Baseline in Participant Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, 12 and 16
timeFrame: Baseline, Weeks 1, 2, 4, 8, 12 and 16
measure: Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Weeks 1, 2, 4, 8 12 and 16
timeFrame: Baseline, Week 1, 2, 4, 8, 12 and 16
measure: Change From Baseline in Physician Global Assessment of Arthritis at Weeks 1, 2, 4, 8, 12 and 16
timeFrame: Baseline, Week 1, 2, 4, 8, 12 and 16
measure: Change From Baseline in C-Reactive Protein (CRP) at Weeks 1, 2, 4, 8, 12 and 16
timeFrame: Baseline, Week 1, 2, 4, 8, 12 and 16
measure: 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
timeFrame: Baseline, Weeks 1, 2, 4, 8, 12 and 16
measure: Number of Participants Who Withdrew From Study Due to Lack of Efficacy
timeFrame: Baseline up to Week 16
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 1, 2, 4, 8, 12 and 16
timeFrame: Baseline, Week 1, 2, 4, 8, 12 and 16
measure: Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12
timeFrame: Baseline, Week 1, 2, 4, 8 and 12
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2 at Weeks 4 and 12
timeFrame: Baseline, Weeks 4, 12
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 16
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline up to Week 16
measure: Number of Participants With Clinically Significant Vital Signs Abnormalities
timeFrame: Baseline up to Week 16
measure: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters
timeFrame: Baseline up to Week 16
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to Week 16
measure: Number of Participants With Clinically Significant Physical Examination Abnormalities
timeFrame: Baseline up to Week 16
measure: Minimum Observed Plasma Pre-dose Concentration (Ctrough Min) of Steady State
timeFrame: Predose
measure: Number of Participants With Concomitant Medications
timeFrame: Baseline up to Week 16
Other outcomes:
Locations:
city: Malvern East
country: Australia
facility: Emeritus Research
state: Victoria
city: Curitiba
country: Brazil
facility: Centro de Estudos em Terapias Inovadoras
state: Paraná
city: Curitiba
country: Brazil
facility: Hospital de Clínicas da UFPR
state: PR
city: São Paulo
country: Brazil
facility: Escola Paulista de Medicina - EPM
state: SP
city: São Paulo
country: Brazil
facility: Hospital Heliópolis - PAM
state: SP
city: Santiago
country: Chile
facility: Hospital del Salvador
state: RM
city: Santiago
country: Chile
facility: Office of Dr. Pedro Miranda
state: RM
city: Santiago
country: Chile
facility: Hospital Clínica San Borja Arriarán
state: RM
city: Viña Del Mar
country: Chile
facility: Hospital Gustavo Fricke
state: V Region
city: Rancagua
country: Chile
facility: Hospital Regional de Rancagua
state: VI Región
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava - Trebovice
country: Czechia
facility: NZZ Bormed, s.r.o.
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Praha 4
country: Czechia
facility: Fakultni Thomayerova nemocnice s poliklinikou
city: Zlin
country: Czechia
facility: PV-Medical s.r.o.
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: North Estonia Regional Hospital
city: Hyderabad
country: India
facility: Department of Rheumatology, CARE Hospital
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Nizam's Institute of Medical Sciences, Department of Rheumatology
state: Andhra Pradesh
city: Bangalore
country: India
facility: St. John's Medical College Hospital, Department of Orthopedics
state: Karnataka
city: Mumbai
country: India
facility: T. N. Medical College and B. Y. L. Nair Ch. HospitalDepartment of Medicine and Rheumatology Clinic
state: Maharashtra
city: Ludhiana
country: India
facility: Dayanand Medical College and Hospital, Department of Orthopedics
state: Punjab
city: Coimbatore
country: India
facility: Kovai Medical Center and Hospital,
state: Tamil NADU
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital/Rheumatology, Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital, Department of Rheumatology
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Kangnam St. Mary's Hospital/ Rheumatology, Internal Medicine
city: Lima
country: Peru
facility: Instituto Peruano del Hueso y la Articulación SAC.
city: Lima
country: Peru
facility: Instituto Peruano del Climaterio
city: Lima
country: Peru
facility: Instituto de Ginecologia y Reproduccion
city: Bialystok
country: Poland
facility: SP ZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego
city: Bialystok
country: Poland
facility: Centrum Osteoporozy i Chorob Kostno-Stawowych
city: Poznan
country: Poland
facility: Poznanski Osrodek Medyczny
city: Warszawa
country: Poland
facility: Centrum Badan Klinicznych
city: Moscow
country: Russian Federation
facility: City Hospital #4, Department of Therapy of Moscow Faculty of Russian State Medical University
city: Moscow
country: Russian Federation
facility: Clinical Hospital #7
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical Academy
city: St. Petersburg
country: Russian Federation
facility: City Hospital # 28 "Maximilianovskaya"
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Clnical Hospital n.a. Sokolov (MSCh #122)
city: Johannesburg
country: South Africa
facility: Office Of Dr. F. Le Clus
state: Gauteng
city: Parktown
country: South Africa
facility: Dr S Sankovic
state: Johannesburg
city: Bloemfontein
country: South Africa
facility: Quinta-Med
city: Durban
country: South Africa
facility: St Augustines Medical Ctr 2
city: Kempton Park
country: South Africa
facility: Clinresco Centres (Pty) Ltd
city: Pretoria
country: South Africa
facility: Intercare Medical and Dental Centre
city: Barakaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Sevilla
country: Spain
facility: Hospital Nuestra Señora de Valme
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: