| 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
|
- Strand V, Mysler E, Moots RJ, Wallenstein GV, DeMasi R, Gruben D, Soma K, Iikuni N, Smolen JS, Fleischmann R. Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial. RMD Open. 2019 Oct 1;5(2):e001040. doi: 10.1136/rmdopen-2019-001040. eCollection 2019.
- Fleischmann R, Mysler E, Hall S, Kivitz AJ, Moots RJ, Luo Z, DeMasi R, Soma K, Zhang R, Takiya L, Tatulych S, Mojcik C, Krishnaswami S, Menon S, Smolen JS; ORAL Strategy investigators. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial. Lancet. 2017 Jul 29;390(10093):457-468. doi: 10.1016/S0140-6736(17)31618-5. Epub 2017 Jun 16.
|
| |
| Completed
|
| 1152
|
| 1080
|
| 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, Older Adult)
|
| No
|
|
Contact information is only displayed when the study is recruiting subjects
|
| Argentina, Australia, Bosnia and Herzegovina, Bulgaria, Canada, Chile, Czechia, Estonia, Israel, Korea, Republic of, Latvia, Lithuania, Mexico, Peru, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States
|
| Croatia, Czech Republic, France
|
| |
| 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
|
| May 2018
|
