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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT00650767
Date of registration:	31/03/2008
Prospective Registration:	No
Primary sponsor:	Array Biopharma, now a wholly owned subsidiary of Pfizer
Public title:	A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
Scientific title:
Date of first enrolment:	March 2008
Target sample size:	201
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00650767
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	Phase 2

Countries of recruitment
Argentina	Brazil	Hungary	Peru	Poland	Romania	United States

Contacts

Name:	Pfizer CT.gov Call Center
Address:
Telephone:
Email:
Affiliation:	Pfizer

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Placebo; oral

Drug: ARRY-438162, MEK inhibitor; oral

Primary Outcome(s)

American College of Rheumatology 20% (ACR20) Response Rate at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) [Time Frame: Week 1]

American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) [Time Frame: Week 12]

American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) [Time Frame: Week 8]

American College of Rheumatology 50% (ACR50) Response Rate at Week 12 [Time Frame: Week 12]

American College of Rheumatology 70% (ACR70) Response Rate at Week 1 [Time Frame: Week 1]

American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up) [Time Frame: Week 16 (Follow-up)]

Health Assessment Questionnaire - Disability Index (HAQ-DI) [Time Frame: Week 16 (Follow-up)]

Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) [Time Frame: Week 16 (Follow-up)]

Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) [Time Frame: Week 12]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain [Time Frame: Week 12]

American College of Rheumatology 50% (ACR50) Response Rate at Week 8 [Time Frame: Week 8]

C-Reactive Protein (CRP) at Week 16 (Follow-up) [Time Frame: Week 16 (Follow-up)]

Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) [Time Frame: Week 2]

Health Assessment Questionnaire - Disability Index (HAQ-DI) [Time Frame: Week 1]

Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) [Time Frame: Week 4]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health [Time Frame: Week 16 (Follow-up)]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health [Time Frame: Week 4]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score [Time Frame: Week 16 (Follow-up)]

American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) [Time Frame: Week 12]

Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) [Time Frame: Week 1]

American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) [Time Frame: Week 4]

American College of Rheumatology 20% (ACR20) Response Rate at Week 2 [Time Frame: Week 2]

American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) [Time Frame: Week 16 (Follow-up)]

American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) [Time Frame: Week 4]

American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) [Time Frame: Week 8]

American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) [Time Frame: Week 16 (Follow-up)]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health [Time Frame: Baseline]

American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) [Time Frame: Week 2]

American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) [Time Frame: Baseline]

American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) [Time Frame: Baseline]

American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up) [Time Frame: Week 16 (Follow-up)]

American College of Rheumatology 50% (ACR50) Response Rate at Week 1 [Time Frame: Week 1]

C-Reactive Protein (CRP) at Week 4 [Time Frame: Week 4]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score [Time Frame: Week 16 (Follow-up)]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional [Time Frame: Week 4]

American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) [Time Frame: Week 2]

American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up) [Time Frame: Week 16 (Follow-up)]

Health Assessment Questionnaire - Disability Index (HAQ-DI) [Time Frame: Week 2]

Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) [Time Frame: Week 2]

American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) [Time Frame: Week 1]

American College of Rheumatology 20% (ACR20) Response Rate at Week 1 [Time Frame: Week 1]

Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) [Time Frame: Week 12]

Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) [Time Frame: Week 8]

American College of Rheumatology 20% (ACR20) Response Rate at Week 4 [Time Frame: Week 4]

American College of Rheumatology 50% (ACR50) Response Rate at Week 2 [Time Frame: Week 2]

American College of Rheumatology 70% (ACR70) Response Rate at Week 12 [Time Frame: Week 12]

American College of Rheumatology 70% (ACR70) Response Rate at Week 4 [Time Frame: Week 4]

C-Reactive Protein (CRP) at Week 1 [Time Frame: Week 1]

Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) [Time Frame: Week 16 (Follow-up)]

American College of Rheumatology 70% (ACR70) Response Rate at Week 8 [Time Frame: Week 8]

C-Reactive Protein (CRP) at Baseline [Time Frame: Baseline]

American College of Rheumatology 50% (ACR50) Response Rate at Week 4 [Time Frame: Week 4]

American College of Rheumatology 70% (ACR70) Response Rate at Week 2 [Time Frame: Week 2]

Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) [Time Frame: Week 12]

Health Assessment Questionnaire - Disability Index (HAQ-DI) [Time Frame: Week 4]

Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) [Time Frame: Week 4]

Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) [Time Frame: Week 8]

Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) [Time Frame: Week 2]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain [Time Frame: Baseline]

Health Assessment Questionnaire - Disability Index (HAQ-DI) [Time Frame: Baseline]

Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) [Time Frame: Week 4]

Health Assessment Questionnaire - Disability Index (HAQ-DI) [Time Frame: Week 12]

Health Assessment Questionnaire - Disability Index (HAQ-DI) [Time Frame: Week 8]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health [Time Frame: Week 12]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score [Time Frame: Week 4]

Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) [Time Frame: Week 16 (Follow-up)]

Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) [Time Frame: Week 1]

Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) [Time Frame: Week 1]

Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) [Time Frame: Week 8]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning [Time Frame: Baseline]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality [Time Frame: Week 12]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score [Time Frame: Week 8]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score [Time Frame: Week 8]

Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) [Time Frame: Week 1]

Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) [Time Frame: Baseline]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health [Time Frame: Week 4]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health [Time Frame: Week 8]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical [Time Frame: Week 4]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning [Time Frame: Week 12]

Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) [Time Frame: Week 12]

Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) [Time Frame: Week 16 (Follow-up)]

Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) [Time Frame: Week 4]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain [Time Frame: Week 4]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning [Time Frame: Week 4]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality [Time Frame: Week 16 (Follow-up)]

Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) [Time Frame: Week 2]

Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) [Time Frame: Week 8]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health [Time Frame: Week 16 (Follow-up)]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning [Time Frame: Week 12]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality [Time Frame: Week 4]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health [Time Frame: Week 12]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score [Time Frame: Baseline]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain [Time Frame: Week 16 (Follow-up)]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain [Time Frame: Week 8]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning [Time Frame: Week 8]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional [Time Frame: Week 12]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical [Time Frame: Week 12]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning [Time Frame: Baseline]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score [Time Frame: Week 4]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning [Time Frame: Week 16 (Follow-up)]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score [Time Frame: Week 12]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning [Time Frame: Week 4]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning [Time Frame: Week 16 (Follow-up)]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical [Time Frame: Baseline]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality [Time Frame: Baseline]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional [Time Frame: Baseline]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional [Time Frame: Week 16 (Follow-up)]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical [Time Frame: Week 16 (Follow-up)]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality [Time Frame: Week 8]

American College of Rheumatology 20% (ACR20) Response Rate at Week 8 [Time Frame: Week 8]

C-Reactive Protein (CRP) at Week 12 [Time Frame: Week 12]

C-Reactive Protein (CRP) at Week 2 [Time Frame: Week 2]

C-Reactive Protein (CRP) at Week 8 [Time Frame: Week 8]

Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) [Time Frame: Baseline]

Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) [Time Frame: Baseline]

Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) [Time Frame: Baseline]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health [Time Frame: Baseline]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health [Time Frame: Week 8]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score [Time Frame: Week 12]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score [Time Frame: Baseline]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional [Time Frame: Week 8]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical [Time Frame: Week 8]

SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning [Time Frame: Week 8]

Secondary ID(s)

ARRAY-162-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	06/11/2016
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00650767

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