Phase 2
N=201
A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00650767 ↗Enrolled (actual)
201
Serious AEs
1.5%
Results posted
Nov 2016
Primary outcome: Primary: American College of Rheumatology 20% (ACR20) Response Rate at Week 12 — 45.1; 58.0; 60.0; 54.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ARRY-438162, MEK inhibitor; oral (Drug); Placebo; oral (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY American College of Rheumatology 20% (ACR20) Response Rate at Week 12 |
45.1; 58.0; 60.0; 54.0 | — |
| SECONDARY American College of Rheumatology 20% (ACR20) Response Rate at Week 1 |
12.2; 20.8; 32.7; 46.0 | — |
| SECONDARY American College of Rheumatology 20% (ACR20) Response Rate at Week 2 |
18.4; 31.3; 32.7; 50.0 | — |
| SECONDARY American College of Rheumatology 20% (ACR20) Response Rate at Week 4 |
44.9; 54.2; 44.9; 58.0 | — |
| SECONDARY American College of Rheumatology 20% (ACR20) Response Rate at Week 8 |
49.0; 56.3; 53.1; 48.0 | — |
| SECONDARY American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up) |
40.8; 52.1; 49.0; 46.0 | — |
| SECONDARY American College of Rheumatology 50% (ACR50) Response Rate at Week 1 |
2.0; 6.3; 2.0; 4.0 | — |
| SECONDARY American College of Rheumatology 50% (ACR50) Response Rate at Week 2 |
6.1; 8.3; 10.2; 16.0 | — |
| SECONDARY American College of Rheumatology 50% (ACR50) Response Rate at Week 4 |
10.2; 8.3; 12.2; 16.0 | — |
| SECONDARY American College of Rheumatology 50% (ACR50) Response Rate at Week 8 |
16.3; 27.1; 16.3; 22.0 | — |
| SECONDARY American College of Rheumatology 50% (ACR50) Response Rate at Week 12 |
24.5; 25.0; 22.4; 22.0 | — |
| SECONDARY American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up) |
16.3; 27.1; 30.6; 14.0 | — |
| SECONDARY American College of Rheumatology 70% (ACR70) Response Rate at Week 1 |
0.0; 2.1; 0.0; 2.0 | — |
| SECONDARY American College of Rheumatology 70% (ACR70) Response Rate at Week 2 |
2.0; 4.2; 0.0; 2.0 | — |
| SECONDARY American College of Rheumatology 70% (ACR70) Response Rate at Week 4 |
0.0; 4.2; 2.0; 2.0 | — |
| SECONDARY American College of Rheumatology 70% (ACR70) Response Rate at Week 8 |
4.1; 4.2; 4.1; 4.0 | — |
| SECONDARY American College of Rheumatology 70% (ACR70) Response Rate at Week 12 |
8.2; 12.5; 8.2; 6.0 | — |
| SECONDARY American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up) |
6.1; 6.3; 6.1; 10.0 | — |
| SECONDARY American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) |
9.1; 7.4; 9.2; 8.9 | — |
| SECONDARY American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) |
9.1; 7.4; 9.2; 8.9 | — |
| SECONDARY American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) |
9.1; 7.4; 9.2; 8.9 | — |
| SECONDARY American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) |
9.1; 7.4; 9.2; 8.9 | — |
| SECONDARY American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) |
9.1; 7.4; 9.2; 8.9 | — |
| SECONDARY American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) |
9.1; 7.4; 9.2; 8.9 | — |
| SECONDARY American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) |
9.1; 7.4; 9.2; 8.9 | — |
| SECONDARY American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) |
6.5; 4.8; 6.9; 6.5 | — |
| SECONDARY American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) |
6.5; 4.8; 6.9; 6.5 | — |
| SECONDARY American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) |
6.5; 4.8; 6.9; 6.5 | — |
| SECONDARY American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) |
6.5; 4.8; 6.9; 6.5 | — |
| SECONDARY American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) |
6.5; 4.8; 6.9; 6.5 | — |
| SECONDARY American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) |
6.5; 4.8; 6.9; 6.5 | — |
| SECONDARY American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) |
6.5; 4.8; 6.9; 6.5 | — |
| SECONDARY Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) |
50.7; 47.1; 48.7; 48.5 | — |
| SECONDARY Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) |
50.7; 47.1; 48.7; 48.5 | — |
| SECONDARY Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) |
50.7; 47.1; 48.7; 48.5 | — |
| SECONDARY Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) |
50.7; 47.1; 48.7; 48.5 | — |
| SECONDARY Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) |
50.7; 47.1; 48.7; 48.5 | — |
| SECONDARY Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) |
50.7; 47.1; 48.7; 48.5 | — |
| SECONDARY Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) |
50.7; 47.1; 48.7; 48.5 | — |
| SECONDARY Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) |
46.9; 42.6; 47.5; 44.8 | — |
| SECONDARY Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) |
46.9; 42.6; 47.5; 44.8 | — |
| SECONDARY Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) |
46.9; 42.6; 47.5; 44.8 | — |
| SECONDARY Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) |
46.9; 42.6; 47.5; 44.8 | — |
| SECONDARY Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) |
46.9; 42.6; 47.5; 44.8 | — |
| SECONDARY Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) |
46.9; 42.6; 47.5; 44.8 | — |
| SECONDARY Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) |
46.9; 42.6; 47.5; 44.8 | — |
| SECONDARY Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) |
36.7; 33.2; 40.7; 34.6 | — |
| SECONDARY Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) |
36.7; 33.2; 40.7; 34.6 | — |
| SECONDARY Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) |
36.7; 33.2; 40.7; 34.6 | — |
| SECONDARY Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) |
36.7; 33.2; 40.7; 34.6 | — |
| SECONDARY Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) |
36.7; 33.2; 40.7; 34.6 | — |
| SECONDARY Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) |
36.7; 33.2; 40.7; 34.6 | — |
| SECONDARY Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) |
36.7; 33.2; 40.7; 34.6 | — |
| SECONDARY Health Assessment Questionnaire - Disability Index (HAQ-DI) |
1.3; 1.2; 1.2; 1.1 | — |
| SECONDARY Health Assessment Questionnaire - Disability Index (HAQ-DI) |
1.3; 1.2; 1.2; 1.1 | — |
| SECONDARY Health Assessment Questionnaire - Disability Index (HAQ-DI) |
1.3; 1.2; 1.2; 1.1 | — |
| SECONDARY Health Assessment Questionnaire - Disability Index (HAQ-DI) |
1.3; 1.2; 1.2; 1.1 | — |
| SECONDARY Health Assessment Questionnaire - Disability Index (HAQ-DI) |
1.3; 1.2; 1.2; 1.1 | — |
| SECONDARY Health Assessment Questionnaire - Disability Index (HAQ-DI) |
1.3; 1.2; 1.2; 1.1 | — |
| SECONDARY Health Assessment Questionnaire - Disability Index (HAQ-DI) |
1.3; 1.2; 1.2; 1.1 | — |
| SECONDARY C-Reactive Protein (CRP) at Baseline |
1.9; 1.8; 2.4; 2.4 | — |
| SECONDARY C-Reactive Protein (CRP) at Week 1 |
2.2; 1.9; 2.0; 1.4 | — |
| SECONDARY C-Reactive Protein (CRP) at Week 2 |
1.9; 1.9; 2.5; 2.1 | — |
| SECONDARY C-Reactive Protein (CRP) at Week 4 |
1.9; 2.2; 2.6; 2.2 | — |
| SECONDARY C-Reactive Protein (CRP) at Week 8 |
2.1; 2.0; 2.6; 3.0 | — |
| SECONDARY C-Reactive Protein (CRP) at Week 12 |
2.1; 1.8; 2.5; 2.9 | — |
| SECONDARY C-Reactive Protein (CRP) at Week 16 (Follow-up) |
1.9; 2.3; 2.0; 2.3 | — |
| SECONDARY Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) |
4.8; 4.4; 4.8; 4.7 | — |
| SECONDARY Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) |
4.8; 4.4; 4.8; 4.7 | — |
| SECONDARY Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) |
4.8; 4.4; 4.8; 4.7 | — |
| SECONDARY Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) |
4.8; 4.4; 4.8; 4.7 | — |
| SECONDARY Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) |
4.8; 4.4; 4.8; 4.7 | — |
| SECONDARY Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) |
4.8; 4.4; 4.8; 4.7 | — |
| SECONDARY Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) |
4.8; 4.4; 4.8; 4.7 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning |
35.4; 36.0; 35.5; 37.8 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning |
35.4; 36.0; 35.5; 37.8 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning |
35.4; 36.0; 35.5; 37.8 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning |
35.4; 36.0; 35.5; 37.8 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning |
35.4; 36.0; 35.5; 37.8 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical |
36.4; 38.9; 36.9; 38.7 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical |
36.4; 38.9; 36.9; 38.7 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical |
36.4; 38.9; 36.9; 38.7 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical |
36.4; 38.9; 36.9; 38.7 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical |
36.4; 38.9; 36.9; 38.7 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain |
37.9; 38.1; 37.0; 38.1 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain |
37.9; 38.1; 37.0; 38.1 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain |
37.9; 38.1; 37.0; 38.1 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain |
37.9; 38.1; 37.0; 38.1 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain |
37.9; 38.1; 37.0; 38.1 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health |
37.4; 36.8; 36.4; 38.3 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health |
37.4; 36.8; 36.4; 38.3 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health |
37.4; 36.8; 36.4; 38.3 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health |
37.4; 36.8; 36.4; 38.3 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health |
37.4; 36.8; 36.4; 38.3 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality |
45.1; 47.4; 44.4; 46.9 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality |
45.1; 47.4; 44.4; 46.9 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality |
45.1; 47.4; 44.4; 46.9 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality |
45.1; 47.4; 44.4; 46.9 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality |
45.1; 47.4; 44.4; 46.9 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning |
37.1; 39.0; 37.2; 38.8 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning |
37.1; 39.0; 37.2; 38.8 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning |
37.1; 39.0; 37.2; 38.8 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning |
37.1; 39.0; 37.2; 38.8 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning |
37.1; 39.0; 37.2; 38.8 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional |
34.4; 36.4; 35.2; 36.1 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional |
34.4; 36.4; 35.2; 36.1 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional |
34.4; 36.4; 35.2; 36.1 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional |
34.4; 36.4; 35.2; 36.1 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional |
34.4; 36.4; 35.2; 36.1 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health |
40.5; 41.4; 37.7; 40.4 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health |
40.5; 41.4; 37.7; 40.4 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health |
40.5; 41.4; 37.7; 40.4 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health |
40.5; 41.4; 37.7; 40.4 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health |
40.5; 41.4; 37.7; 40.4 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score |
40.4; 42.3; 39.3; 41.1 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score |
40.4; 42.3; 39.3; 41.1 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score |
40.4; 42.3; 39.3; 41.1 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score |
40.4; 42.3; 39.3; 41.1 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score |
40.4; 42.3; 39.3; 41.1 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score |
37.1; 37.6; 37.2; 39.0 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score |
37.1; 37.6; 37.2; 39.0 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score |
37.1; 37.6; 37.2; 39.0 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score |
37.1; 37.6; 37.2; 39.0 | — |
| SECONDARY SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score |
37.1; 37.6; 37.2; 39.0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00650767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.