Clinical trial NCT00883896: Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis
Official title: RANDOMIZED, PARALLEL, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ILV-094 ADMINISTERED SUBCUTANEOUSLY TO SUBJECT WITH RHEUMATOID ARTHRITIS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
ACR
Methotrexate
Interleukin-22
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-20
Enrollment: 195
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: The primary objective of this study is to assess the safety and efficacy of different dose regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with active rheumatoid arthritis who are taking methotrexate.


Eligibility criteria: Inclusion Criteria:

* Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
* Active RA at the time of screening and baseline consisting of \>= 5 swollen and \>= 5 tender joints (28-joint count) and at least 1 of the following at screening: C-reactive protein \>= 10 mg/L or Erythrocyte Sedimentation Rate \>= 28 mm/h
* Must be receiving methotrexate for at least 12 weeks, with a stable route and dose (up to 25 mg weekly) for at least 8 weeks prior to the baseline visit.

Exclusion Criteria:

* Subjects with other rheumatic diseases
* Cancer or history of cancer (other than cutaneous basal cell carcinoma and squamous cell carcinoma or in situ cervical cancer)
* Any prior use of B cell-depleting therapy

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10
timeFrame: Week 2, 4, 6, 8, 10
measure: Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12
timeFrame: Week 2, 4, 6, 8, 10, 12
measure: Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12
timeFrame: Week 2, 4, 6, 8, 10, 12
measure: Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP)
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 12
measure: Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 12
measure: Tender Joints Counts (TJC)
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 12
measure: Swollen Joints Count (SJC)
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 12
measure: Physician Global Assessment of Disease Activity
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 12
measure: Participant Global Assessment of Disease Activity
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 12
measure: Pain Visual Analog Scale (VAS)
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 12
measure: General Health Visual Analog Scale (VAS)
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 12
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
timeFrame: Baseline, Week 4, 2, 6, 8, 10, 12
measure: 36-Item Short-Form Health Survey (SF-36)
timeFrame: Baseline, Week 4, 8, 12
measure: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
timeFrame: Baseline, Week 4, 8, 12
measure: Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
timeFrame: Week 2, 4, 6, 8, 10, 12
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Palm Harbor
country: United States
facility: Arthritis Center
state: Florida
city: Sarasota
country: United States
facility: Clinical Research Advantage, Inc.
state: Florida
city: Sarasota
country: United States
facility: The Arthritis Specialty Centre
state: Florida
city: Indianapolis
country: United States
facility: Diagnostic Rheumatology and Research PC
state: Indiana
city: Saint Louis
country: United States
facility: Clayton Medical Research
state: Missouri
city: Cincinnati
country: United States
facility: Deaconess Hospital
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: West Reading
country: United States
facility: Clinical Research Center of Reading
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading, LLC
state: Pennsylvania
city: Dallas
country: United States
facility: Arthritis Care and Diagnostic Center
state: Texas
city: San Antonio
country: United States
facility: Arthritis & Osteoporosis Center of South Texas
state: Texas
city: Antwerpen
country: Belgium
facility: AZ Jan Palfijn
city: Brussels
country: Belgium
facility: Cliniques Universitaires St Luc Avenue Hippocrate 10 UCL
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Hasselt
country: Belgium
facility: Reuma Instituut
city: Liege
country: Belgium
facility: Chu Liege Sart Tilman B 35
city: Barranquilla
country: Colombia
facility: Centro de Reumatologia y Ortopedia
state: Atlantico
city: Bogota
country: Colombia
facility: Fundacion Instituto de Reumatologia Fernando Chalem
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Medicity S.A.S
state: Santander
city: Bucaramanga
country: Colombia
facility: Servimed EU
state: Santander
city: Rijeka
country: Croatia
facility: University Hospital Centre Rijeka
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
city: München
country: Germany
facility: Klinikum Innenstadt der Ludwig-Maximillians-Universität
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Hospital
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Nyiregyhaza
country: Hungary
facility: Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft.
city: Szombathely
country: Hungary
facility: Markusovszky Hospital
city: Yotsukaidou
country: Japan
facility: National Hospital Organization Shimoshizu National Hospital
state: Chiba
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Sagamihara
country: Japan
facility: National Hospital Organization Sagamihara National Hospital
state: Kanagawa
city: Kurashiki
country: Japan
facility: Medical Corporation Wakoukai Kurashiki Kousai Hospital
state: Okayama
city: Shinjyuku-ku
country: Japan
facility: Institute of Rheumatology, Tokyo Women's Medical University Hospital
state: Tokyo
city: Gunma
country: Japan
facility: Inoue Hospital
city: Hyogo
country: Japan
facility: Matsubara Clinic
city: Hyogo
country: Japan
facility: Matsubara Mayflower Hospital
city: Jalisco
country: Mexico
facility: Centro de Estudio de Investigacion Basica y Clinica S.C
state: Guadalajara
city: Amsterdam
country: Netherlands
facility: AMC
state: Noord-Holland
city: Cluj-Napoca
country: Romania
facility: Centrul Medical Terra Med
state: Cluj
city: Bucuresti
country: Romania
facility: SC Duo Medical SRL
city: Bucuresti
country: Romania
facility: Spitalul Clinic Sf. Maria
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
city: Bucuresti
country: Romania
facility: Centrul de Boli Reumatismale Dr. I. Stoia
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Tg Mures
city: Ekaterinburg
country: Russian Federation
facility: Municipal Institution City Clinical Hospital #40
city: Moscow
country: Russian Federation
facility: Institute of Rheumatology of Russian academy of Medical Scie
city: Moscow
country: Russian Federation
facility: City Clinical Hospital # 1 n.a. Pirogov
city: Saint Petersburg
country: Russian Federation
facility: State Educational Institution of Additional Professional Education
city: Saint Petersburg
country: Russian Federation
facility: State Health care institution of Leningrad Regional Clinical Hospital
city: Smolensk
country: Russian Federation
facility: State education institution of higher vocational education Smolensk State Medical Academy Roszdrav
city: Yaroslavl
country: Russian Federation
facility: State Healthcare Institution Yaroslavl Regional Clinical Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: