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An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, 35801-4414 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rhematoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT02187055
Pfizer
Completed
An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate

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An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate
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
To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab. To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or adalimumab.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rhematoid Arthritis
  • Drug: 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
  • Drug: 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
  • Biological: 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
  • Experimental: Tofacitinib 5 mg twice daily with methotrexate
    Intervention: Drug: Tofacitinib with methotrexate
  • Experimental: Tofacitinib 5 mg twice daily monotherapy
    Intervention: Drug: Tofacitinib without methotrexate
  • Active Comparator: Adalimumab with methotrexate
    Intervention: Biological: Adalimumab with methotrexate
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1132
December 2016
December 2016   (Final data collection date for primary outcome measure)

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

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Bosnia and Herzegovina,   Bulgaria,   Canada,   Chile,   Czech Republic,   Estonia,   France,   Israel,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
Croatia
 
NCT02187055
A3921187
2014-000358-13 ( EudraCT Number )
ORAL STRATEGY ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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