Clinical trial NCT00661661: Long-Term, Open-Label Study Of CP-690,550 For Treatment Of Rheumatoid Arthritis In Japan
Official title: A Long-term, Open-label Study Of Cp-690,550 to Confirm The Safety Following Long Term Administration Of Cp-690,550 In The Treatment Of Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Long term open label study in Japan
CP-690
550
tofacitinib
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 487
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are only eligible for this study after they have completed participation in another "qualifying" study of CP-690,550.


Eligibility criteria: Inclusion Criteria:

* Subjects who have completed their participation in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis

Exclusion Criteria:

* Serious medical conditions that would make treatment with CP-690,550 potentially unsafe

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 288
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
timeFrame: Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
timeFrame: Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
timeFrame: Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
timeFrame: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
measure: Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
timeFrame: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
measure: Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
timeFrame: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
measure: Change From Baseline in Patient Global Assessment of Arthritis
timeFrame: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
measure: Change From Baseline in Physician Global Assessment of Arthritis
timeFrame: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
measure: Change From Baseline in Patient Assessment of Arthritis Pain
timeFrame: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
measure: Change From Baseline in Tender/Painful Joint Counts
timeFrame: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
measure: Change From Baseline in Swollen Joint Counts
timeFrame: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
measure: Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS)
timeFrame: First visit in the study (Month 24 in Study A3921044), Weeks 24, 48, and 96
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: National hospital Organization Nagoya Medical Center
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Narashino
country: Japan
facility: Chiba-ken Saiseikai Narashino Hospital
state: Chiba
city: Yotukaidou
country: Japan
facility: Shimoshizu National Hospital
state: Chiba
city: Iiduka
country: Japan
facility: Aso Iizuka Hospital
state: Fukuoka
city: Kitakyusyu
country: Japan
facility: University of Occupational and Environmental Health Hospital
state: Fukuoka
city: Kurume
country: Japan
facility: St. Mary's Hospital
state: Fukuoka
city: Sawara-ku
country: Japan
facility: SHONO Rheumatism Clinic
state: Fukuoka
city: Takasaki
country: Japan
facility: Inoue Hospital
state: Gunma
city: Higashihiroshima
country: Japan
facility: Higashihiroshima Memorial Hospital
state: Hiroshima
city: Hiroshima-city
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
state: Hiroshima
city: Asahikawa
country: Japan
facility: Katayama Orthopedic Rheumatology Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo city general hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido Medical Center for Rheumatic Diseases
state: Hokkaido
city: Nishinomiya
country: Japan
facility: The Hospital of Hyogo College of Medicine
state: Hyogo
city: Hitachi-shi
country: Japan
facility: Taga General Hospital
state: Ibaraki
city: Tsukuba
country: Japan
facility: Tsukuba University Hospital
state: Ibaraki
city: Sagamihara
country: Japan
facility: National Hospital Organization Sagamihara National Hospital
state: Kanagawa
city: Koushi
country: Japan
facility: Kumamoto Saishunso National Hospital
state: Kumamoto
city: Tsu
country: Japan
facility: National hospital Organization Mie Chuou Medical Center
state: Mie
city: Sendai
country: Japan
facility: Hikarigaoka Spellman Hospital
state: Miyagi
city: Ohmura
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
state: Nagasaki
city: Sasebo
country: Japan
facility: Sasebo Chuo Hospital
state: Nagasaki
city: Kashihara
country: Japan
facility: Higami hospital
state: Nara
city: Kawachinagano
country: Japan
facility: National Hospital Organization Osaka Minami Center
state: Osaka
city: Ureshino
country: Japan
facility: Ureshino Medical Center
state: Saga
city: Kawagoe-shi
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Kitamoto
country: Japan
facility: Kitasato University Kitasato Institute Medical Center Hospital
state: Saitama
city: Hamamatsu
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Arakawa-ku
country: Japan
facility: Tokyo Women's Medical University Medical Center East
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Sasaki Foundation Kyoundo Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: Juntendo Tokyo Koto Geriatric Medical Center
state: Tokyo
city: Meguro-ku
country: Japan
facility: National Hospital Organization Tokyo Medical Center
state: Tokyo
city: Musashimurayama-shi
country: Japan
facility: National Hospital Organization MURAYAMA Medical Center
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Fukuhara Hospital
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Tokyo Women's Medical University, Institute of Rheumatology
state: Tokyo
city: Chiba
country: Japan
facility: National Hospital Organization Chiba-East Hospital
city: Fukuoka
country: Japan
facility: Kondo clinic for rheumatism and orthopaedics
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka
country: Japan
facility: Medical Co.LTA PS Clinic
city: Fukusima
country: Japan
facility: Fukusima Daiichi Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Rheumatology Clinic
city: Kumamoto
country: Japan
facility: Kumamoto Orthopaedic Hospital
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Miyagi
country: Japan
facility: Sendai Taihaku Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital of Medicine and Dentistry
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Oita
country: Japan
facility: A Medical Corporation Oribe Rheumatism Internist Clinic
city: Osaka
country: Japan
facility: The Tazuke Kofukai Medical Research Institute Kitano Hospital
city: Saitama
country: Japan
facility: Saitama city hospital
city: Shinjuku-ku, Tokyo
country: Japan
facility: Keio University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
citation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.
citation: van der Heijde D, Landewe RBM, Wollenhaupt J, Strengholt S, Terry K, Kwok K, Wang L, Cohen S. Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies. Rheumatology (Oxford). 2021 Apr 6;60(4):1708-1716. doi: 10.1093/rheumatology/keaa476.
citation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
citation: Fleischmann R, Wollenhaupt J, Takiya L, Maniccia A, Kwok K, Wang L, van Vollenhoven RF. Safety and maintenance of response for tofacitinib monotherapy and combination therapy in rheumatoid arthritis: an analysis of pooled data from open-label long-term extension studies. RMD Open. 2017 Dec 18;3(2):e000491. doi: 10.1136/rmdopen-2017-000491. eCollection 2017.
citation: Fleischmann R, Wollenhaupt J, Cohen S, Wang L, Fan H, Bandi V, Andrews J, Takiya L, Bananis E, Weinblatt ME. Effect of Discontinuation or Initiation of Methotrexate or Glucocorticoids on Tofacitinib Efficacy in Patients with Rheumatoid Arthritis: A Post Hoc Analysis. Rheumatol Ther. 2018 Jun;5(1):203-214. doi: 10.1007/s40744-018-0093-7. Epub 2018 Feb 7.
citation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.
citation: Yamanaka H, Tanaka Y, Takeuchi T, Sugiyama N, Yuasa H, Toyoizumi S, Morishima Y, Hirose T, Zwillich S. Tofacitinib, an oral Janus kinase inhibitor, as monotherapy or with background methotrexate, in Japanese patients with rheumatoid arthritis: an open-label, long-term extension study. Arthritis Res Ther. 2016 Jan 28;18:34. doi: 10.1186/s13075-016-0932-2.
citation: Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.