Clinical trial NCT00650767: A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Array BioPharma
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 201
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 is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in patients on stable doses of methotrexate, and to further evaluate the safety of the study drug. Approximately 200 patients from the US, Argentina, Brazil, Hungary, Peru, Poland and Romania will be enrolled in this study.


Eligibility criteria: Key Inclusion Criteria:

* Diagnosis of rheumatoid arthritis, based on the American College of Rheumatology (ACR) 1987 Revised Criteria, prior to first dose of study drug.
* Patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose of study drug and is willing to continue on this regimen for the duration of the study.
* Patient has received a stable dose of folate for ≥ 6 weeks and is willing to continue on this regimen for the duration of the study.
* No prior use of biological agents for the treatment of rheumatoid arthritis.
* Additional criteria exist.

Key Exclusion Criteria:

* Diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere with disease activity assessments or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
* A history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with rheumatoid arthritis.
* Additional criteria exist.

Primary outcomes:
measure: American College of Rheumatology 20% (ACR20) Response Rate at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: American College of Rheumatology 20% (ACR20) Response Rate at Week 1
timeFrame: Week 1
measure: American College of Rheumatology 20% (ACR20) Response Rate at Week 2
timeFrame: Week 2
measure: American College of Rheumatology 20% (ACR20) Response Rate at Week 4
timeFrame: Week 4
measure: American College of Rheumatology 20% (ACR20) Response Rate at Week 8
timeFrame: Week 8
measure: American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up)
timeFrame: Week 16 (Follow-up)
measure: American College of Rheumatology 50% (ACR50) Response Rate at Week 1
timeFrame: Week 1
measure: American College of Rheumatology 50% (ACR50) Response Rate at Week 2
timeFrame: Week 2
measure: American College of Rheumatology 50% (ACR50) Response Rate at Week 4
timeFrame: Week 4
measure: American College of Rheumatology 50% (ACR50) Response Rate at Week 8
timeFrame: Week 8
measure: American College of Rheumatology 50% (ACR50) Response Rate at Week 12
timeFrame: Week 12
measure: American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up)
timeFrame: Week 16 (Follow-up)
measure: American College of Rheumatology 70% (ACR70) Response Rate at Week 1
timeFrame: Week 1
measure: American College of Rheumatology 70% (ACR70) Response Rate at Week 2
timeFrame: Week 2
measure: American College of Rheumatology 70% (ACR70) Response Rate at Week 4
timeFrame: Week 4
measure: American College of Rheumatology 70% (ACR70) Response Rate at Week 8
timeFrame: Week 8
measure: American College of Rheumatology 70% (ACR70) Response Rate at Week 12
timeFrame: Week 12
measure: American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up)
timeFrame: Week 16 (Follow-up)
measure: American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
timeFrame: Baseline
measure: American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
timeFrame: Week 1
measure: American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
timeFrame: Week 2
measure: American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
timeFrame: Week 4
measure: American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
timeFrame: Week 8
measure: American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
timeFrame: Week 12
measure: American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
timeFrame: Week 16 (Follow-up)
measure: American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
timeFrame: Baseline
measure: American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
timeFrame: Week 1
measure: American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
timeFrame: Week 2
measure: American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
timeFrame: Week 4
measure: American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
timeFrame: Week 8
measure: American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
timeFrame: Week 12
measure: American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
timeFrame: Week 16 (Follow-up)
measure: Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
timeFrame: Baseline
measure: Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
timeFrame: Week 1
measure: Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
timeFrame: Week 2
measure: Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
timeFrame: Week 4
measure: Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
timeFrame: Week 8
measure: Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
timeFrame: Week 12
measure: Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
timeFrame: Week 16 (Follow-up)
measure: Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
timeFrame: Baseline
measure: Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
timeFrame: Week 1
measure: Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
timeFrame: Week 2
measure: Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
timeFrame: Week 4
measure: Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
timeFrame: Week 8
measure: Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
timeFrame: Week 12
measure: Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
timeFrame: Week 16 (Follow-up)
measure: Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
timeFrame: Baseline
measure: Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
timeFrame: Week 1
measure: Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
timeFrame: Week 2
measure: Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
timeFrame: Week 4
measure: Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
timeFrame: Week 8
measure: Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
timeFrame: Week 12
measure: Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
timeFrame: Week 16 (Follow-up)
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: Baseline
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: Week 1
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: Week 2
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: Week 4
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: Week 8
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: Week 12
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: Week 16 (Follow-up)
measure: C-Reactive Protein (CRP) at Baseline
timeFrame: Baseline
measure: C-Reactive Protein (CRP) at Week 1
timeFrame: Week 1
measure: C-Reactive Protein (CRP) at Week 2
timeFrame: Week 2
measure: C-Reactive Protein (CRP) at Week 4
timeFrame: Week 4
measure: C-Reactive Protein (CRP) at Week 8
timeFrame: Week 8
measure: C-Reactive Protein (CRP) at Week 12
timeFrame: Week 12
measure: C-Reactive Protein (CRP) at Week 16 (Follow-up)
timeFrame: Week 16 (Follow-up)
measure: Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
timeFrame: Baseline
measure: Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
timeFrame: Week 1
measure: Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
timeFrame: Week 2
measure: Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
timeFrame: Week 4
measure: Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
timeFrame: Week 8
measure: Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
timeFrame: Week 12
measure: Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
timeFrame: Week 16 (Follow-up)
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
timeFrame: Baseline
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
timeFrame: Week 4
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
timeFrame: Week 8
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
timeFrame: Week 12
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
timeFrame: Week 16 (Follow-up)
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
timeFrame: Baseline
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
timeFrame: Week 4
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
timeFrame: Week 8
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
timeFrame: Week 12
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
timeFrame: Week 16 (Follow-up)
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
timeFrame: Baseline
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
timeFrame: Week 4
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
timeFrame: Week 8
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
timeFrame: Week 12
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
timeFrame: Week 16 (Follow-up)
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
timeFrame: Baseline
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
timeFrame: Week 4
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
timeFrame: Week 8
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
timeFrame: Week 12
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
timeFrame: Week 16 (Follow-up)
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
timeFrame: Baseline
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
timeFrame: Week 4
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
timeFrame: Week 8
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
timeFrame: Week 12
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
timeFrame: Week 16 (Follow-up)
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
timeFrame: Baseline
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
timeFrame: Week 4
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
timeFrame: Week 8
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
timeFrame: Week 12
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
timeFrame: Week 16 (Follow-up)
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
timeFrame: Baseline
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
timeFrame: Week 4
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
timeFrame: Week 8
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
timeFrame: Week 12
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
timeFrame: Week 16 (Follow-up)
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
timeFrame: Baseline
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
timeFrame: Week 4
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
timeFrame: Week 8
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
timeFrame: Week 12
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
timeFrame: Week 16 (Follow-up)
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
timeFrame: Baseline
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
timeFrame: Week 4
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
timeFrame: Week 8
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
timeFrame: Week 12
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
timeFrame: Week 16 (Follow-up)
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
timeFrame: Baseline
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
timeFrame: Week 4
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
timeFrame: Week 8
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
timeFrame: Week 12
measure: SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
timeFrame: Week 16 (Follow-up)
Other outcomes:
Locations:
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Buenos Aires
country: Argentina
facility: Asistencia Integral en Reumatologia
city: Buenos Aires
country: Argentina
facility: CEMIC
city: Buenos Aires
country: Argentina
facility: Hospital Britanico
city: San Juan
country: Argentina
facility: CER San Juan
city: San Miguel de Tucumán
country: Argentina
facility: Centro Medico Privado de Reumatologia
city: Santa Fe
country: Argentina
facility: Centro de Investigaciones Clinicas del Litoral SRL
city: Goiânia
country: Brazil
facility: Médicos Unidos Ltda.
state: GO
city: Curitiba
country: Brazil
facility: CETI - Hospital das Clínicas da Universidade Federal do Paraná
state: PR
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da da Pontifícia Universidade Católica do Rio Grande do Sul
state: RS
city: São Paulo
country: Brazil
facility: Hospital São Paulo / Instituto Paulista de Reumatologia
state: SP
city: São Paulo
country: Brazil
facility: Hospital Heliópolis
state: SP
city: São Paulo
country: Brazil
facility: Instituto de Medicina Avançada (IMA Brasil)
state: SP
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Kórház - Allergólógia és Immunológia
city: Budapest
country: Hungary
facility: Synexus Ltd Hungary
city: Gyula
country: Hungary
facility: Békés Megyei Pándy Kálmán Kórház - Rheumatology
city: Mezőkövesd
country: Hungary
facility: Mozgasszervi Rehabilitacios Kozpont
city: Szolnok
country: Hungary
facility: MÁV Kórház - Clinical Pharmacology
city: Szombathely
country: Hungary
facility: Vas Megyei Markusovszky Korhaz Lajos Általános, Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktató Kórház, Zártkörűen Működő Nonprofit Részvénytársaság - Rheumatology
city: Székesfehérvár
country: Hungary
facility: Fejér Megyei Szent György Kórház - Rheumatology
city: Arequipa
country: Peru
facility: Instituto de Investigacion y Seguridad Medica EIRL
city: Lima
country: Peru
facility: Clinica San Felipe - Centro de Estudios Clinicos CGYM
city: Lima
country: Peru
facility: Clínica Ricardo Palma- Sitio de Investigacion de Reumatologia
city: Lima
country: Peru
facility: Hospital Maria Auxiliadora - Centro de Investigaciones Medicas
city: Bialystok
country: Poland
facility: Centrum Osteoporozy i Chorób Kostno-Stawowych
city: Elblag
country: Poland
facility: Wojewódzki Szpital Zespolony - Oddział Reumatologiczny
city: Gdynia
country: Poland
facility: Centrum Leczenia Chorob Cywilizacyjnych
city: Lublin
country: Poland
facility: NZOZ Reumed
city: Warszawa
country: Poland
facility: Centrum Leczenia Chorob Cywilizacyjnych
city: Wroclaw
country: Poland
facility: Synexus SCM Sp. z o.o.
city: Bucuresti
country: Romania
facility: Spitalul Clinic "Sf, Maria"
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta
city: Timisoara
country: Romania
facility: Cabinet Medical "Prof. Dr. Miorara Banciu"
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: