Phase 3
Completed N=843
A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT01638013 ↗
Enrolled (actual)
843
Serious AEs
23.6%
Results posted
Oct 2020
Primary outcomePrimary: Number of Participants With Adverse Events — 193; 208; 395; 175 Participants
◆ Published Evidence
Established
31citations · ~5 / year
Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan.
Summary
This study evaluated the safety and efficacy of long-term administration of ASP015K in patients who have completed Phase IIb or Phase III studies.
Linked Publications (2)
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Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan.
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Safety and Effectiveness of Peficitinib (ASP015K) in Patients with Rheumatoid Arthritis: Final Results (32 Months of Mean Peficitinib Treatment) From a Long-Term, Open-Label Extension Study in Japan, Korea, and Taiwan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
193; 208; 395; 175; 160; 321 | — |
| SECONDARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 |
29.5; 82.5; 86.2; 37.0; 42.2; 47.2 | — |
| SECONDARY Percentage of Participants With an ACR50-CRP Response Through Week 372 |
8.5; 62.8; 67.5; 9.5; 14.1; 23.1 | — |
| SECONDARY Percentage of Participants With an ACR70-CRP Response Through Week 372 |
3.5; 42.2; 45.9; 4.5; 6.0; 9.0 | — |
| SECONDARY Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 |
28.5; 80.3; 85.7; 37.0; 42.2; 45.7 | — |
| SECONDARY Percentage of Participants With an ACR50-ESR Response Through Week 372 |
8.0; 58.3; 65.3; 9.0; 13.1; 21.6 | — |
| SECONDARY Percentage of Participants With an ACR70-ESR Response Through Week 372 |
2.5; 36.8; 41.3; 4.0; 5.5; 7.0 | — |
| SECONDARY Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 |
-0.71; -2.67; -2.79; -1.04; -1.09; -1.41 | — |
| SECONDARY Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 |
-0.70; -2.70; -2.83; -1.03; -1.11; -1.43 | — |
| SECONDARY Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 |
8.0; 55.4; 58.2; 13.0; 16.1; 15.1 | — |
| SECONDARY Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 |
4.5; 30.9; 38.0; 4.5; 7.0; 7.6 | — |
| SECONDARY Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 |
18.5; 73.7; 72.7; 24.5; 25.1; 33.2 | — |
| SECONDARY Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 |
8.5; 56.5; 55.7; 13.5; 14.6; 14.2 | — |
| SECONDARY Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 |
-4.3; -11.7; -11.5; -5.3; -5.7; -7.7 | — |
| SECONDARY Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 |
-3.8; -9.6; -10.5; -4.6; -4.8; -6.1 | — |
| SECONDARY Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 |
-0.334; -1.590; -1.932; -0.752; -0.745; -1.032 | — |
| SECONDARY Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 |
-2.46; -22.66; -27.02; -6.65; -6.93; -10.54 | — |
| SECONDARY Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 |
1.5; 18.3; 22.4; 4.0; 5.0; 4.5 | — |
| SECONDARY Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 |
11.5; 71.0; 71.0; 18.0; 19.6; 27.1 | — |
| SECONDARY Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 |
7.0; 54.7; 54.5; 11.5; 13.1; 13.7 | — |
| SECONDARY Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 |
41.5; 89.7; 93.4; 54.5; 59.3; 70.1 | — |
| SECONDARY Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 |
48.5; 94.2; 94.6; 60.5; 65.8; 75.4 | — |
| SECONDARY Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 |
4.0; 24.6; 32.6; 5.0; 6.0; 5.5 | — |
| SECONDARY Change From Baseline of Preceding Study in SDAI Score Through Week 372 |
-7.41; -24.30; -25.12; -10.13; -10.93; -14.33 | — |
| SECONDARY Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 |
3.0; 23.7; 30.6; 4.0; 4.5; 6.0 | — |
| SECONDARY Change From Baseline of Preceding Study CDAI Score Through Week 372 |
-7.07; -22.70; -23.22; -9.38; -10.19; -13.30 | — |
| SECONDARY Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 |
1.71; 4.50; 3.29; 4.15; 4.85; 5.91 | — |
| SECONDARY Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 |
-5.36; -2.20; -4.81; -3.29; -4.52; -3.30 | — |
| SECONDARY Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 |
-21.05; -22.18; -21.94; -24.79; -20.70; -25.17 | — |
| SECONDARY Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 |
-22.24; -22.20; -22.45; -25.78; -20.80; -25.32 | — |
| SECONDARY Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 |
-28.16; -25.39; -27.38; -29.31; -27.81; -28.85 | — |
| SECONDARY Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 |
37.0; 61.2; 62.1; 38.5; 38.7; 39.7 | — |
| SECONDARY Change From Baseline of Preceding Study in HAQ-DI Through Week 372 |
-0.03; -0.43; -0.49; -0.07; -0.08; -0.13 | — |
| SECONDARY Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 |
35.0; 59.2; 67.0; 37.0; 40.7; 41.7 | — |
| SECONDARY Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 |
-10.77; -41.57; -43.09; -13.48; -16.78; -20.59 | — |
| SECONDARY Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 |
-6.82; -37.24; -35.60; -11.31; -13.42; -17.89 | — |
| SECONDARY Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 |
-7.37; -36.09; -34.79; -11.21; -13.10; -17.70 | — |
| SECONDARY Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 |
-0.55; 11.62; 11.60; 0.30; 1.53; 2.52 | — |
| SECONDARY Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 |
3.00; 2.94; 2.69; 3.88; 3.85; 4.72 | — |
| SECONDARY Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 |
-0.52; 5.21; 5.45; 0.29; 1.30; 1.70 | — |
| SECONDARY Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 |
34.0; 70; 71.1; 33.7; 40.2; 39.4 | — |
| SECONDARY Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 |
43.0; 39.9; 37.4; 42.7; 47.2; 43.4 | — |
| SECONDARY Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 |
26.0; 44.8; 48.5; 27.6; 35.7; 39.9 | — |
| SECONDARY Number of Participants Who Withdrew Due to Lack of Efficacy |
19.4; 4.9; 3.4 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has completed treatment with the study drug in studies RAJ1, RAJ3 or RAJ4 as specified in the protocol
- The subject himself/herself wishes to continue taking the study drug, and the investigator or sub-investigator deems continued administration to be necessary or appropriate
Exclusion Criteria
- There were abnormal findings in the x-ray taken at Week 0, and an acute or chronic infection, tuberculosis infection, or malignancy is suspected
- Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for human immunodeficiency virus (HIV) infection
- Subject has concurrent autoimmune disease (except Sjogren's syndrome) other than RA or a history of it
- Subject has a clinically significant infection or disease (requiring hospitalization or parenteral therapy)
- Subject has QTc < 300 msec on ECG measurements performed at the study site at Week 52 of studies RAJ3 or RAJ4 and has QTc < 300 msec at retest.
Data sourced from ClinicalTrials.gov (NCT01638013) and the linked publication. 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. Informational only — not medical advice.