Clinical trial NCT02281552: A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis
Official title: A Multicenter, Randomized, Double-blind, Parallel-group, Phase 3 Study To Demonstrate Non-inferiority For The Efficacy Of A Once Daily Dose Of Tofacitinib Modified Release Tablet To A Twice Daily Dose Of The Immediate Release Tablet In Adult Patients With Rheumatoid Arthritis On Background Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Tofacitinib, CP-690,550, Janis kinase, JAK inhibitor, modified release, Xeljanz
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-11-02
Enrollment: 209
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib modified release tablet taken once a day in patients with rheumatoid arthritis who continue taking methotrexate. Results for the modified release tablets will be compared to the efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in patients with rheumatoid arthritis who continue taking methotrexate.


Eligibility criteria: Inclusion Criteria:

* diagnosis of rheumatoid arthritis
* currently taking a stable dose of methotrexate
* no evidence of active or latent or inadequately treated tuberculosis

Exclusion Criteria:

* evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease
* clinically significant infections within the past 6 months

Primary outcomes:
measure: Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C-Reactive Protein [CRP]) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants Achieving an American College of Rheumatology 20 Percent [%] (ACR20) Response at Week 12
timeFrame: Week 12
measure: Number of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12
timeFrame: Week 12
measure: Number of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Week 12
timeFrame: Week 12
measure: Number of Participants With DAS Remission (DAS28-4-CRP <2.6) at Week 12
timeFrame: Week 12
measure: Number of Participants With DAS Remission (DAS28-4-ESR <2.6) at Week 12
timeFrame: Week 12
measure: Number of Participants With Low Disease Activity (DAS28-4-CRP <=3.2) at Week 12
timeFrame: Week 12
measure: Number of Participants With Low Disease Activity (DAS28-4-ESR <=3.2) at Week 12
timeFrame: Week 12
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ Scores) at Week 12
timeFrame: Week 12
measure: Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in the Short Form 36 (SF-36) Health Survey Component Scores at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Scores at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in the European Quality of Life - 5 Dimensions Questionnaire (EQ-5D) Scores at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
measure: Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 12 weeks
measure: Number of Participants With Clinically Significant Laboratory Test Abnormalities
timeFrame: Baseline up to 12 weeks
Locations:
city: Nagoya
country: Japan
facility: Japanese Red Cross Nagoya Daiichi Hospital
state: Aichi
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Toyohashi
country: Japan
facility: National Hospital Organization Toyohashi Medical Center
state: Aichi
city: Matsuyama
country: Japan
facility: Yamada Rheumatology Clinic
state: Ehime
city: Kurume
country: Japan
facility: St. Mary's Hospital
state: Fukuoka
city: Takasaki-shi
country: Japan
facility: Gunma Rheumatism Clinic
state: Gunma
city: Tohrimachi, Takasaki
country: Japan
facility: Inoue Hospital
state: Gunma
city: Hiroshima-city
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
state: Hiroshima
city: Asahikawa
country: Japan
facility: National Hospital Organization Asahikawa Medical Center
state: Hokkaido
city: Asahikawa
country: Japan
facility: Katayama Orthopaedic Rheumatology Clinic
state: Hokkaido
city: Morioka
country: Japan
facility: Yoshida orthopaedics and rheumatologyclinic
state: Iwate
city: Morioka
country: Japan
facility: Komagamine Rheumatoid Orthopaedic Clinic
state: Iwate
city: Sagamihara
country: Japan
facility: National Hospital Organization Sagamihara National Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: National Hospital Organization Yokohama Medical Center
state: Kanagawa
city: Oosaki
country: Japan
facility: Osaki Citizen Hospital
state: Miyagi
city: Sendai
country: Japan
facility: Tohoku University Hospital/ Department of Hematology and Rheumatology
state: Miyagi
city: Nagano-shi
country: Japan
facility: Nagano Red Cross Hospital
state: Nagano
city: Sasebo
country: Japan
facility: Sasebo Chuo Hospital
state: Nagasaki
city: Ureshino-shi
country: Japan
facility: National Hospital Organization Ureshino Medical Center
state: Saga
city: Setagaya-ku
country: Japan
facility: Soshigayaokura clinic
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Takaoka-shi
country: Japan
facility: Honjo Rheumatism Clinic
state: Toyama
city: Shunan
country: Japan
facility: Miyasato Clinic
state: Yamaguchi
city: Chiba
country: Japan
facility: National Hospital Organization Chiba-East Hospital
city: Fukui
country: Japan
facility: Sugimoto rheumatology and internal medicine clinic
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka
country: Japan
facility: SHONO Rheumatism Clinic
city: Hokkaido
country: Japan
facility: Sagawa Akira Rheumatology Clinic
city: Hyogo
country: Japan
facility: Matsubara Mayflower Hospital
city: Kanagawa
country: Japan
facility: Yokohama Minami Kyosai Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Orthopaedic Hospital
city: Kyoto
country: Japan
facility: Japanese Red Cross Kyoto Daiichi Hospital
city: Oita
country: Japan
facility: Oribe Clinic of Rheumatology and Internal Medicine
city: Oita
country: Japan
facility: Otsuka Clinic of Rheumatism and Medicine
city: Saitama
country: Japan
facility: Rabbit Clinic
city: Saitama
country: Japan
facility: Hirose Clinic
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Tanaka Y, Sugiyama N, Toyoizumi S, Lukic T, Lamba M, Zhang R, Chen C, Stock T, Valdez H, Mojcik C, Fan H, Deng C, Yuasa H. Modified- versus immediate-release tofacitinib in Japanese rheumatoid arthritis patients: a randomized, phase III, non-inferiority study. Rheumatology (Oxford). 2019 Jan 1;58(1):70-79. doi: 10.1093/rheumatology/key250.