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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02187055




Registration number
NCT02187055
Ethics application status
Date submitted
8/07/2014
Date registered
10/07/2014
Date last updated
27/06/2018

Titles & IDs
Public title
An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate
Scientific title
A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis
Secondary ID [1] 0 0
2014-000358-13
Secondary ID [2] 0 0
A3921187
Universal Trial Number (UTN)
Trial acronym
ORAL STRATEGY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rhematoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tofacitinib with methotrexate
Treatment: Drugs - Tofacitinib without methotrexate
Treatment: Other - Adalimumab with methotrexate

Experimental: Tofacitinib 5 mg twice daily with methotrexate -

Experimental: Tofacitinib 5 mg twice daily monotherapy -

Active comparator: Adalimumab with methotrexate -


Treatment: Drugs: Tofacitinib with methotrexate
Tofacitinib 5 mg twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months

Treatment: Drugs: Tofacitinib without methotrexate
Tofacitinib 5 mg twice daily, oral for 12 months Placebo for methotrexate (previous stable dose) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months

Treatment: Other: Adalimumab with methotrexate
Placebo for tofacitinib twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Adalimumab 40 mg every other week, subcutaneous for 12 months
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6
Timepoint [1] 0 0
Month 6
Secondary outcome [1] 0 0
Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6
Timepoint [1] 0 0
Month 6
Secondary outcome [2] 0 0
Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6
Timepoint [2] 0 0
Month 6
Secondary outcome [3] 0 0
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6
Timepoint [3] 0 0
Month 6
Secondary outcome [4] 0 0
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6
Timepoint [4] 0 0
Month 6
Secondary outcome [5] 0 0
Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6
Timepoint [5] 0 0
Month 6
Secondary outcome [6] 0 0
Percentage of Participants Achieving SDAI =3.3 at Month 6
Timepoint [6] 0 0
Month 6
Secondary outcome [7] 0 0
Percentage of Participants Achieving CDAI =2.8 at Month 6
Timepoint [7] 0 0
Month 6
Secondary outcome [8] 0 0
Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6
Timepoint [8] 0 0
Month 6
Secondary outcome [9] 0 0
Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6
Timepoint [9] 0 0
Month 6
Secondary outcome [10] 0 0
Percentage of Participants Achieving SDAI =11 at Month 6
Timepoint [10] 0 0
Month 6
Secondary outcome [11] 0 0
Percentage of Participants Achieving CDAI =10 at Month 6
Timepoint [11] 0 0
Month 6
Secondary outcome [12] 0 0
Percentage of Participants Achieving DAS28-4 (ESR) =3.2 at Month 6
Timepoint [12] 0 0
Month 6
Secondary outcome [13] 0 0
Percentage of Participants Achieving DAS28-4 (CRP) =3.2 at Month 6
Timepoint [13] 0 0
Month 6
Secondary outcome [14] 0 0
Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6
Timepoint [14] 0 0
Month 6
Secondary outcome [15] 0 0
Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6
Timepoint [15] 0 0
Month 6
Secondary outcome [16] 0 0
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6
Timepoint [16] 0 0
Month 6
Secondary outcome [17] 0 0
Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6
Timepoint [17] 0 0
Month 6
Secondary outcome [18] 0 0
Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6
Timepoint [18] 0 0
Month 6
Secondary outcome [19] 0 0
Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6
Timepoint [19] 0 0
Month 6
Secondary outcome [20] 0 0
Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6
Timepoint [20] 0 0
Month 6
Secondary outcome [21] 0 0
Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6
Timepoint [21] 0 0
Month 6
Secondary outcome [22] 0 0
Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6
Timepoint [22] 0 0
Month 6
Secondary outcome [23] 0 0
Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6
Timepoint [23] 0 0
Month 6
Secondary outcome [24] 0 0
Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6
Timepoint [24] 0 0
Month 6
Secondary outcome [25] 0 0
Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6
Timepoint [25] 0 0
Month 6
Secondary outcome [26] 0 0
Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6
Timepoint [26] 0 0
Month 6
Secondary outcome [27] 0 0
Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6
Timepoint [27] 0 0
Month 6
Secondary outcome [28] 0 0
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6
Timepoint [28] 0 0
Month 6
Secondary outcome [29] 0 0
Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6
Timepoint [29] 0 0
Month 6
Secondary outcome [30] 0 0
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6
Timepoint [30] 0 0
Month 6

Eligibility
Key inclusion criteria
* Have moderate to severe rheumatoid arthritis
* On methotrexate but inadequately controlled
* Subjects must not have active tuberculosis or an inadequately treated tuberculosis infection
* Subjects must use contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects who have been previously treated with adalimumab or Tofacitinib
* Subjects with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
* Subjects with specific laboratory test abnormalities
* Subjects with specific types of infections

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
1152
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Pacific Private Clinic - Southport
Recruitment hospital [3] 0 0
QML Pathology - Southport
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [5] 0 0
Emeritus Research - Malvern East
Recruitment hospital [6] 0 0
RK Will Pty Ltd - Victoria Park
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
3145 - Malvern East
Recruitment postcode(s) [5] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
North Dakota
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Tucuman
Country [25] 0 0
Argentina
State/province [25] 0 0
San Juan
Country [26] 0 0
Bosnia and Herzegovina
State/province [26] 0 0
Republika Srpska
Country [27] 0 0
Bosnia and Herzegovina
State/province [27] 0 0
Tuzla
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Pleven
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Plovdiv
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Ruse
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Shumen
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Sofia
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Targovisthe
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Chile
State/province [36] 0 0
Metropolitana
Country [37] 0 0
Chile
State/province [37] 0 0
Valparaiso
Country [38] 0 0
Chile
State/province [38] 0 0
X Region
Country [39] 0 0
Czechia
State/province [39] 0 0
Czech Republic
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Czechia
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Brno
Country [41] 0 0
Czechia
State/province [41] 0 0
Ceska Lipa
Country [42] 0 0
Czechia
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Ostrava- Moravska Ostrava
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Czechia
State/province [43] 0 0
Praha 4
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Estonia
State/province [44] 0 0
Parnu
Country [45] 0 0
Estonia
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Tallinn
Country [46] 0 0
Israel
State/province [46] 0 0
Haifa
Country [47] 0 0
Israel
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Jerusalem
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Israel
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Tel-Hashomer
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Korea, Republic of
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Incheon
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Korea, Republic of
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Daegu
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Seoul
Country [53] 0 0
Latvia
State/province [53] 0 0
Riga
Country [54] 0 0
Lithuania
State/province [54] 0 0
Alytus
Country [55] 0 0
Lithuania
State/province [55] 0 0
Kaunas
Country [56] 0 0
Lithuania
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Siauliai
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Mexico
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Coahuila
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Sinaloa
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Mexico
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Yucatan
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Mexico
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Chihuahua
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Mexico
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San Luis Potosi
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Peru
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Arequipa
Country [65] 0 0
Peru
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Lima
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Philippines
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Batangas
Country [67] 0 0
Philippines
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Davao DEL SUR
Country [68] 0 0
Philippines
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Iloilo
Country [69] 0 0
Philippines
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Metro Manila
Country [70] 0 0
Philippines
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Cebu City
Country [71] 0 0
Philippines
State/province [71] 0 0
Davao
Country [72] 0 0
Philippines
State/province [72] 0 0
Iloilo City
Country [73] 0 0
Poland
State/province [73] 0 0
Malopolska
Country [74] 0 0
Poland
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WOJ Mazowieckie
Country [75] 0 0
Poland
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Bydgoszcz
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Bytom
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Elblag
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Poland
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Gdynia
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State/province [79] 0 0
Katowice
Country [80] 0 0
Poland
State/province [80] 0 0
Lodz
Country [81] 0 0
Poland
State/province [81] 0 0
Nadarzyn
Country [82] 0 0
Poland
State/province [82] 0 0
Poznan
Country [83] 0 0
Poland
State/province [83] 0 0
Warszawa
Country [84] 0 0
Poland
State/province [84] 0 0
Wroclaw
Country [85] 0 0
Romania
State/province [85] 0 0
Cluj
Country [86] 0 0
Romania
State/province [86] 0 0
Covasna
Country [87] 0 0
Romania
State/province [87] 0 0
Maramures
Country [88] 0 0
Romania
State/province [88] 0 0
Bucuresti
Country [89] 0 0
Romania
State/province [89] 0 0
Galati
Country [90] 0 0
Romania
State/province [90] 0 0
Iasi
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Karelia Republic
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Kemerovo
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Moscow
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Novosibirsk
Country [95] 0 0
Russian Federation
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Orenburg
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Russian Federation
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Ryazan
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Russian Federation
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Saint Petersburg
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Samara
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Saratov
Country [100] 0 0
Russian Federation
State/province [100] 0 0
Smolensk
Country [101] 0 0
Russian Federation
State/province [101] 0 0
Yaroslavl
Country [102] 0 0
South Africa
State/province [102] 0 0
FREE State
Country [103] 0 0
South Africa
State/province [103] 0 0
Gauteng
Country [104] 0 0
South Africa
State/province [104] 0 0
Kwazulu-natal
Country [105] 0 0
South Africa
State/province [105] 0 0
Western CAPE
Country [106] 0 0
Spain
State/province [106] 0 0
A Coruna
Country [107] 0 0
Spain
State/province [107] 0 0
Barcelona
Country [108] 0 0
Spain
State/province [108] 0 0
Madrid
Country [109] 0 0
Spain
State/province [109] 0 0
Malaga
Country [110] 0 0
Spain
State/province [110] 0 0
Sevilla
Country [111] 0 0
Taiwan
State/province [111] 0 0
Taiwan ROC
Country [112] 0 0
Taiwan
State/province [112] 0 0
Hualien
Country [113] 0 0
Taiwan
State/province [113] 0 0
Kaohsiung
Country [114] 0 0
Taiwan
State/province [114] 0 0
Taipei
Country [115] 0 0
Taiwan
State/province [115] 0 0
Taoyuan County
Country [116] 0 0
Thailand
State/province [116] 0 0
Rajthevi
Country [117] 0 0
Thailand
State/province [117] 0 0
Bangkok
Country [118] 0 0
Thailand
State/province [118] 0 0
Songkhla
Country [119] 0 0
Turkey
State/province [119] 0 0
Ankara
Country [120] 0 0
Turkey
State/province [120] 0 0
Samsun
Country [121] 0 0
Turkey
State/province [121] 0 0
Sivas
Country [122] 0 0
United Kingdom
State/province [122] 0 0
WEST Midlands
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Cannock
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Leeds
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Liverpool
Country [126] 0 0
United Kingdom
State/province [126] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02187055