Clinical trial NCT00938587: A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis
Official title: A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO-CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Glucocorticoids Prednisone
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-14
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety and efficacy of an investigational drug, PF-04171327 on the signs and symptoms of rheumatoid arthritis in patients that require glucocorticoids while on background methotrexate. This study will also look at the response of chemical and biological markers in rheumatoid arthritis patients. Lastly, this study will measure the PK (amount of drug in the blood) of methotrexate while patients may be taking PF-04171327.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years of age, diagnosed with rheumatoid arthritis for a minimum duration of 3 months
* On stable dose of methotrexate for at least 6 weeks prior to screening
* Patient must have minimum disease activity level of ≥ 6 tender/painful joints, ≥ 6 swollen joints and CRP ≥ 0.7 mg/dL
* Not currently receiving steroid medication

Exclusion Criteria:

* Pregnant or nursing women
* Patients that have active infections, TB, HIV and/or Hepatitis B or C
* Patients that have a history of intolerance or significant adverse effects with the use of glucocorticoids

Primary outcomes:
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14
timeFrame: Baseline, Day 14
Secondary outcomes:
measure: Change From Baseline in Tender Joints Count at Day 7, 14, 42
timeFrame: Baseline, Day 7, 14, 42
measure: Change From Baseline in Swollen Joints Count at Day 7, 14 and 42
timeFrame: Baseline, Day 7, 14, 42
measure: Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42
timeFrame: Baseline, Day 7, 14, 42
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14
timeFrame: Baseline, Day 7, 14
measure: Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14
timeFrame: Baseline, Day 7, 14
measure: Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14
timeFrame: Baseline, Day 7, 14
measure: Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14
timeFrame: Baseline, Day 7, 14
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14
timeFrame: Baseline, Day 14 (D14)
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42
timeFrame: Baseline, Day 7, 14, 42
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 7
timeFrame: Baseline, Day 7
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14
timeFrame: Day 7, 14
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14
timeFrame: Day 7, 14
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14
timeFrame: Day 7, 14
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 45
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
timeFrame: Baseline up to Day 45
measure: Change From Baseline in Body Weight at Day 7 and 14
timeFrame: Baseline, Day 7, 14
measure: Number of Participants With Clinically Significant Vital Signs Abnormalities
timeFrame: Baseline up to Day 45
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to Day 45
measure: Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14
timeFrame: 0, 1, 2, 3 and 4 hours post-dose on Day 7, 14
measure: Ratio of Apparent Oral Clearance on Day 1 to Day 14 of Methotrexate
timeFrame: Pre-dose (0 hour), 1, 2, 3 and 4 hours post-dose
measure: Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14
timeFrame: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14
measure: Change From Baseline in Neutrophil Counts at Day 1, 7 and 14
timeFrame: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14
measure: Change From Baseline in Eosinophil Counts at Day 1, 7 and 14
timeFrame: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14
measure: Change From Baseline in Osteocalcin Level at Day 1, 7 and 14
timeFrame: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14
measure: Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14
timeFrame: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14
measure: Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14
timeFrame: Baseline, Day 7 and 14
measure: Change From Baseline in Adiponectin Level at Day 7 and 14
timeFrame: Baseline, Day 7 and 14
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Anniston Medical Clinic, PC
state: Alabama
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Daytona Beach
country: United States
facility: Allergy, Asthma, Arthritis and Lung
state: Florida
city: Miami
country: United States
facility: Elite Research Institute
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, PA
state: Florida
city: Springfield
country: United States
facility: The Arthritis Center
state: Illinois
city: Bingham Farms
country: United States
facility: Premier Imaging Center
state: Michigan
city: Bingham Farms
country: United States
facility: Quest Research Institute
state: Michigan
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Ceske Budejovice
country: Czechia
facility: MEDIPONT Plus, s.r.o.
city: Hostivice
country: Czechia
facility: ARTMEDI UPD s r.o.
city: Praha 11 - Chodov
country: Czechia
facility: DC Mediscan
city: Praha 4
country: Czechia
facility: Revmatologicka ambulance
city: Praha 4
country: Czechia
facility: Fakultni Thomayerova nemocnice s poliklinikou
city: New Territories
country: Hong Kong
facility: Centre for Assessment and Treatment of Rheumatic Diseases, Department of Medicine and Geriatrics
city: Bekescsaba
country: Hungary
facility: Dr. Rethy Pal Korhaz es Rendelointezet\Reumatologia
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum
city: Szolnok
country: Hungary
facility: MAV Korhaz es Rendelointezet
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine, Rheumatology, Internal Medicine
city: Moscow
country: Russian Federation
facility: Moscow SHI City Clinical Hospital #4, Department of Therapy of Moscow Faculty
city: Moscow
country: Russian Federation
facility: Institution of Russian Academy of Medical Sciences Research Institute of Rheumatology RAMS
city: Saint-Petersburg
country: Russian Federation
facility: SI Saint-Petersburg SRI for Emergency Care named after I.I. Dzhanelidze
city: Smolensk
country: Russian Federation
facility: Regional State Institution of Healthcare Smolensk Regional Clinical Hospital
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Niska Banja
country: Serbia
facility: Institute for Rheumatic and Cardiovascular Disease Niska Banja
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Piestany
country: Slovakia
facility: Narodny ustav reumatickych chorob, Klinicke oddelenie
city: Zilina
country: Slovakia
facility: Nestatna reumatologicka ambulancia, MUDr. Pavol Polak, s.r.o.
city: Santiago de Compostela
country: Spain
facility: Hospital Nuestra Señora de La Esperanza
state: A Coruña
city: Baracaldo
country: Spain
facility: Hospital de Cruces
state: Bilbao
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Ankara
country: Turkey
facility: Ankara University School fo Medicine
city: Kharkiv
country: Ukraine
facility: Chair of Cardiology & Functional Diagnostic
city: Kyiv
country: Ukraine
facility: State Institution "Institute of Gerontology of AMS of Ukraine"
city: Kyiv
country: Ukraine
facility: State Institution 'Institute of Gerontology of AMS of Ukraine'
city: Lviv
country: Ukraine
facility: Municipal City Clinical Hospital #4, Department of Rheumatology
city: Vinnitsa
country: Ukraine
facility: Vinnitsa Regional Clinical Hospital n.a. Pirogov
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: