A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K

NCT ID: NCT01638013

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 843 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-13
• Study Completion Date: 2019-09-30

Brief 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.

Detailed Description

This study was an extension study conducted as an open-label multicenter study in rheumatoid arthritis (RA) participants who completed the Phase IIb Study of ASP015K [015K-CL-RAJ1 (hereinafter referred to as study RAJ1)], Phase III Study of ASP015K [015K-CL-RAJ3 (RAJ3)], or Phase III Study of ASP015K [015K-CL-RAJ4 (RAJ4)]. After the marketing approval in Japan on 26 Mar 2019, this study continued as "post marketing clinical study" in Japan. In Taiwan and Korea, this study continued as "clinical study".

Participants received oral ASP015K once daily (QD) after breakfast. The ASP015K dose was increased later for participants who have no safety problems but showed lack of efficacy.

The duration of treatment with the study drug was differed depending upon the participants.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants who completed 015K-CL-RAJ1

Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50 milligrams (mg) peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.

Group Type: EXPERIMENTAL

Peficitinib

Intervention Type: DRUG

Oral Tablet

Participants who completed 015K-CL-RAJ3

Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.

Group Type: EXPERIMENTAL

Peficitinib

Intervention Type: DRUG

Oral Tablet

Participants who completed 015K-CL-RAJ4

Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.

Group Type: EXPERIMENTAL

Peficitinib

Intervention Type: DRUG

Oral Tablet

Interventions

Peficitinib

Oral Tablet

Intervention Type: DRUG

Other Intervention Names

ASP015K; Smyraf

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

JP00037

Nagoya, Aichi-ken, Japan

JP00109

Nagoya, Aichi-ken, Japan

JP00130

Nagoya, Aichi-ken, Japan

JP00175

Nagoya, Aichi-ken, Japan

JP00066

Okazaki, Aichi-ken, Japan

JP00140

Toyoake, Aichi-ken, Japan

JP00108

Toyohashi, Aichi-ken, Japan

JP00170

Toyohashi, Aichi-ken, Japan

JP00156

Toyota, Aichi-ken, Japan

JP00068

Yatomi, Aichi-ken, Japan

JP00180

Asahi, Chiba, Japan

JP00166

Funabashi, Chiba, Japan

JP00102

Kamagaya, Chiba, Japan

JP00115

Narashino, Chiba, Japan

JP00138

Yotsukaidō, Chiba, Japan

JP00120

Iizuka, Fukuoka, Japan

JP00040

Kitakyushu, Fukuoka, Japan

JP00119

Kitakyushu, Fukuoka, Japan

JP00071

Kurume, Fukuoka, Japan

JP00106

Kurume, Fukuoka, Japan

JP00033

Takasaki, Gunma, Japan

JP00163

Higashihiroshima, Hiroshima, Japan

JP00124

Tomakomai, Hokaido, Japan

JP00026

Asahikawa, Hokkaido, Japan

JP00090

Hakodate, Hokkaido, Japan

JP00172

Kitami, Hokkaido, Japan

JP00125

Kushiro, Hokkaido, Japan

JP00001

Sapporo, Hokkaido, Japan

JP00002

Sapporo, Hokkaido, Japan

JP00003

Sapporo, Hokkaido, Japan

JP00031

Sapporo, Hokkaido, Japan

JP00038

Sapporo, Hokkaido, Japan

JP00114

Sapporo, Hokkaido, Japan

JP00158

Sapporo, Hokkaido, Japan

JP00056

Akashi, Hyōgo, Japan

JP00069

Himeji, Hyōgo, Japan

JP00136

Itami, Hyōgo, Japan

JP00041

Katō, Hyōgo, Japan

JP00012

Kobe, Hyōgo, Japan

JP00042

Kobe, Hyōgo, Japan

JP00092

Kobe, Hyōgo, Japan

JP00154

Kobe, Hyōgo, Japan

JP00171

Kobe, Hyōgo, Japan

JP00117

Nishinomiya, Hyōgo, Japan

JP00107

Hitachi, Ibaraki, Japan

JP00181

Hitachi-Naka, Ibaraki, Japan

JP00073

Koga, Ibaraki, Japan

JP00054

Mito, Ibaraki, Japan

JP00039

Tsukuba, Ibaraki, Japan

JP00034

Komatsu, Ishikawa-ken, Japan

JP00179

Komatsu, Ishikawa-ken, Japan

JP00028

Morioka, Iwate, Japan

JP00049

Morioka, Iwate, Japan

JP00088

Kida-gun, Kagawa-ken, Japan

JP00084

Isehara, Kanagawa, Japan

JP00058

Kawasaki, Kanagawa, Japan

JP00141

Sagamihara, Kanagawa, Japan

JP00096

Yokohama, Kanagawa, Japan

JP00045

Zushi, Kanagawa, Japan

JP00019

Kōshi, Kumamoto, Japan

JP00057

Tamana, Kumamoto, Japan

JP00168

Yokkaichi, Mie-ken, Japan

JP00023

Miyagi-gun, Miyagi, Japan

JP00169

Ōsaki, Miyagi, Japan

JP00004

Sendai, Miyagi, Japan

JP00027

Sendai, Miyagi, Japan

JP00036

Sendai, Miyagi, Japan

JP00105

Sendai, Miyagi, Japan

JP00151

Sendai, Miyagi, Japan

JP00050

Hyūga, Miyazaki, Japan

JP00129

Matsumoto, Nagano, Japan

JP00162

Isehaya, Nagasaki, Japan

JP00101

Ōmura, Nagasaki, Japan

JP00103

Ōmura, Nagasaki, Japan

JP00153

Sasebo, Nagasaki, Japan

JP00094

Kashihara, Nara, Japan

JP00025

Nagaoka, Niigata, Japan

JP00144

Shibata, Niigata, Japan

JP00064

Beppu, Oita Prefecture, Japan

JP00051

Setouchi, Okayama-ken, Japan

JP00011

Hannan, Osaka, Japan

JP00134

Higashiosaka, Osaka, Japan

JP00078

Kawachi-Nagano, Osaka, Japan

JP00137

Sakai, Osaka, Japan

JP00070

Suita, Osaka, Japan

JP00086

Suita, Osaka, Japan

JP00146

Suita, Osaka, Japan

JP00061

Toyonaka, Osaka, Japan

JP00075

Ureshino, Saga-ken, Japan

JP00126

Gyōda, Saitama, Japan

JP00007

Hiki-gun, Saitama, Japan

JP00060

Kawagoe, Saitama, Japan

JP00161

Kawagoe, Saitama, Japan

JP00062

Kawaguchi, Saitama, Japan

JP00052

Sayama, Saitama, Japan

JP00008

Tokorozawa, Saitama, Japan

JP00133

Kakegawa, Shizuoka, Japan

JP00077

Kanuma, Tochigi, Japan

JP00145

Shimotsuke, Tochigi, Japan

JP00024

Bunkyo-ku, Tokyo, Japan

JP00043

Bunkyo-ku, Tokyo, Japan

JP00143

Bunkyo-ku, Tokyo, Japan

JP00149

Bunkyo-ku, Tokyo, Japan

JP00152

Bunkyo-ku, Tokyo, Japan

JP00095

Chiyoda-ku, Tokyo, Japan

JP00099

Chiyoda-ku, Tokyo, Japan

JP00142

Chuo-ku, Tokyo, Japan

JP00063

Hachiōji, Tokyo, Japan

JP00053

Kiyose, Tokyo, Japan

JP00072

Meguro-ku, Tokyo, Japan

JP00083

Meguro-ku, Tokyo, Japan

JP00148

Ōta-ku, Tokyo, Japan

JP00100

Setagaya-ku, Tokyo, Japan

JP00081

Shibuya-ku, Tokyo, Japan

JP00032

Shinjuku-ku, Tokyo, Japan

JP00021

Sumida-ku, Tokyo, Japan

JP00010

Takaoka, Toyama, Japan

JP00155

Nishimuro-gun, Wakayama, Japan

JP00104

Shimonoseki, Yamaguchi, Japan

JP00047

Shūnan, Yamaguchi, Japan

JP00176

Fukui, , Japan

JP00018

Fukuoka, , Japan

JP00020

Fukuoka, , Japan

JP00035

Fukuoka, , Japan

JP00059

Fukuoka, , Japan

JP00076

Fukuoka, , Japan

JP00131

Fukuoka, , Japan

JP00164

Fukuoka, , Japan

JP00165

Fukushima, , Japan

JP00013

Hiroshima, , Japan

JP00014

Hiroshima, , Japan

JP00015

Hiroshima, , Japan

JP00016

Hiroshima, , Japan

JP00055

Hiroshima, , Japan

JP00065

Kagoshima, , Japan

JP00074

Kagoshima, , Japan

JP00167

Kagoshima, , Japan

JP00093

Kochi, , Japan

JP00022

Kumamoto, , Japan

JP00046

Kumamoto, , Japan

JP00085

Kyoto, , Japan

JP00123

Kyoto, , Japan

JP00159

Kyoto, , Japan

JP00122

Miyazaki, , Japan

JP00080

Nagano, , Japan

JP00174

Nagano, , Japan

JP00098

Nagasaki, , Japan

JP00112

Nagasaki, , Japan

JP00147

Nagasaki, , Japan

JP00006

Niigata, , Japan

JP00118

Okayama, , Japan

JP00150

Osaka, , Japan

JP00157

Osaka, , Japan

JP00017

Ōita, , Japan

JP00044

Shizuoka, , Japan

JP00089

Shizuoka, , Japan

JP00135

Shizuoka, , Japan

JP00009

Toyama, , Japan

JP00139

Toyama, , Japan

KR00504

Daegu, , South Korea

KR00505

Gwangju, , South Korea

KR00506

Incheon, , South Korea

KR00508

Jeonju, , South Korea

KR00501

Seoul, , South Korea

KR00502

Seoul, , South Korea

KR00509

Seoul, , South Korea

KR00511

Seoul, , South Korea

KR00507

Suwon, , South Korea

TW00709

Kaohsiung City, , Taiwan

TW00710

Taichung, , Taiwan

TW00712

Tainan City, , Taiwan

TW00701

Taipei, , Taiwan

TW00702

Taipei, , Taiwan

TW00711

Taipei, , Taiwan

TW00703

Taoyuan District, , Taiwan

Countries

Japan; South Korea; Taiwan

References

Takeuchi T, Tanaka Y, Tanaka S, Kawakami A, Song YW, Chen YH, Rokuda M, Izutsu H, Ushijima S, Kaneko Y. 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. Rheumatol Ther. 2021 Mar;8(1):425-442. doi: 10.1007/s40744-021-00280-5. Epub 2021 Mar 3.

Reference Type: DERIVED

PMID: 33656739 (View on PubMed)

Takeuchi T, Tanaka Y, Tanaka S, Kawakami A, Song YW, Chen YH, Rokuda M, Izutsu H, Ushijima S, Kaneko Y, Nakashima Y, Shiomi T, Yamada E. 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. Arthritis Res Ther. 2020 Mar 12;22(1):47. doi: 10.1186/s13075-020-2125-2.

Reference Type: DERIVED

PMID: 32164762 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://astellasclinicalstudyresults.com/study.aspx?ID=370

Link to results on the Astellas Clinical Study Results website.

Other Identifiers

015K-CL-RAJ2

Identifier Type: -

Identifier Source: org_study_id