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Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

NCT ID: NCT00960440

Last Updated: 2018-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

399 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-03-31

Brief Summary

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This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.

Detailed Description

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Conditions

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Arthritis, Rheumatoid

Keywords

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randomized double-blind placebo-controlled investigational drug oral therapy safety and efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sequence 1

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period.

Sequence 2

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period.

Sequence 3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period.

CP-690,550

Intervention Type DRUG

Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period.

Sequence 4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period.

CP-690,550

Intervention Type DRUG

Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study period.

Interventions

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CP-690,550

Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period.

Intervention Type DRUG

CP-690,550

Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period.

Intervention Type DRUG

Placebo

Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period.

Intervention Type DRUG

CP-690,550

Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period.

Intervention Type DRUG

Placebo

Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period.

Intervention Type DRUG

CP-690,550

Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study period.

Intervention Type DRUG

Other Intervention Names

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double-blind, placebo-controlled phase double-blind, extension phase double-blind, placebo-controlled phase double-blind, extension phase

Eligibility Criteria

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Inclusion Criteria

* Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.

Exclusion Criteria

* Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

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Los Angeles, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Farmington, Connecticut, United States

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Trumbull, Connecticut, United States

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Aventura, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Boise, Idaho, United States

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Idaho Falls, Idaho, United States

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Springfield, Illinois, United States

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Indianapolis, Indiana, United States

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New Orleans, Louisiana, United States

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Portland, Maine, United States

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Cumberland, Maryland, United States

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Worcester, Massachusetts, United States

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Flowood, Mississippi, United States

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Tupelo, Mississippi, United States

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Lebanon, New Hampshire, United States

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Voorhees Township, New Jersey, United States

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Rocky Mount, North Carolina, United States

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Bethlehem, Pennsylvania, United States

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Willow Grove, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Hixson, Tennessee, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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Vancouver, Washington, United States

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Vancouver, Washington, United States

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Vancouver, Washington, United States

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Kogarah, New South Wales, Australia

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Daw Park, South Australia, Australia

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Heidelberg, Victoria, Australia

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Vienna, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Genk, , Belgium

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Hasselt, , Belgium

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Kortrijk, , Belgium

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Liège, , Belgium

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Goiânia, Goiás, Brazil

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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Winnipeg, Manitoba, Canada

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Hamilton, Ontario, Canada

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Hamilton, Ontario, Canada

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Ottawa, Ontario, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Amiens, , France

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Lyon, , France

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Orléans, , France

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Orléans, , France

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Paris, , France

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Paris, , France

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Berlin, , Germany

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Berlin, , Germany

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Cologne, , Germany

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Erlangen, , Germany

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Frankfurt am Main, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Leipzig, , Germany

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Rheine, , Germany

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Würzburg, , Germany

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Croom, Co. Limerick, Ireland

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Dublin, , Ireland

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Florence, , Italy

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Iesi, , Italy

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San Juan, , Puerto Rico

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Busan, , South Korea

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Daegu, , South Korea

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Seoul, , South Korea

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Santiago de Compostela, A Coruña, Spain

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Mérida, Badajoz, Spain

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Bilbao, Bizkaia, Spain

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Santander, Cantabria, Spain

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Barakaldo, Vizcaya, Spain

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Madrid, , Spain

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Valencia, , Spain

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Niao Sung Hsiang, Kaohsiung County, Taiwan

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Kweishan, Taoyuan County, Taiwan

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Changhua, , Taiwan

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Kaohsiung City, , Taiwan

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Countries

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United Kingdom United States Australia Austria Belgium Brazil Canada France Germany Ireland Italy Puerto Rico South Korea Spain Taiwan

References

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Burmester GR, Blanco R, Charles-Schoeman C, Wollenhaupt J, Zerbini C, Benda B, Gruben D, Wallenstein G, Krishnaswami S, Zwillich SH, Koncz T, Soma K, Bradley J, Mebus C; ORAL Step investigators. Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. Lancet. 2013 Feb 9;381(9865):451-60. doi: 10.1016/S0140-6736(12)61424-X. Epub 2013 Jan 5.

Reference Type DERIVED
PMID: 23294500 (View on PubMed)

Hetland ML, Strangfeld A, Bonfanti G, Soudis D, Deuring JJ, Edwards RA. Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib. Arthritis Res Ther. 2024 Aug 27;26(1):153. doi: 10.1186/s13075-024-03376-9.

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Wright GC, Mysler E, Kwok K, Cadatal MJ, Germino R, Yndestad A, Kinch CD, Ogdie A. Impact of Race on the Efficacy and Safety of Tofacitinib in Rheumatoid Arthritis: Post Hoc Analysis of Pooled Clinical Trials. Rheumatol Ther. 2024 Oct;11(5):1135-1164. doi: 10.1007/s40744-024-00677-y. Epub 2024 Jul 3.

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PMID: 38958913 (View on PubMed)

Citera G, Jain R, Irazoque F, Madariaga H, Gruben D, Wang L, Stockert L, Santana K, Ebrahim A, Ponce de Leon D. Tofacitinib Efficacy in Patients with Rheumatoid Arthritis and Probable Depression/Anxiety: Post Hoc Analysis of Phase 3 and 3b/4 Randomized Controlled Trials. Rheumatol Ther. 2024 Feb;11(1):35-50. doi: 10.1007/s40744-023-00612-7. Epub 2023 Nov 5.

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PMID: 37925660 (View on PubMed)

Charles-Schoeman C, Hyde C, Guan S, Parikh N, Wang J, Shahbazian A, Stockert L, Andrews J. Relationship Between Paraoxonase-1 Genotype and Activity, and Major Adverse Cardiovascular Events and Malignancies in Patients With Rheumatoid Arthritis Receiving Tofacitinib. J Rheumatol. 2023 Jul 15:jrheum.2023-0112. doi: 10.3899/jrheum.2023-0112. Online ahead of print.

Reference Type DERIVED
PMID: 37453736 (View on PubMed)

Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.

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PMID: 36931693 (View on PubMed)

Dougados M, Taylor PC, Bingham CO 3rd, Fallon L, Brault Y, Roychoudhury S, Wang L, Kessouri M. The effect of tofacitinib on residual pain in patients with rheumatoid arthritis and psoriatic arthritis. RMD Open. 2022 Sep;8(2):e002478. doi: 10.1136/rmdopen-2022-002478.

Reference Type DERIVED
PMID: 36814062 (View on PubMed)

Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022.

Reference Type DERIVED
PMID: 36601090 (View on PubMed)

Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5.

Reference Type DERIVED
PMID: 36600185 (View on PubMed)

Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.

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PMID: 36526796 (View on PubMed)

Dikranian AH, Gonzalez-Gay MA, Wellborne F, Alvaro-Gracia JM, Takiya L, Stockert L, Paulissen J, Shi H, Tatulych S, Curtis JR. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: an analysis of pooled data from phase 3 studies. RMD Open. 2022 May;8(1):e002103. doi: 10.1136/rmdopen-2021-002103.

Reference Type DERIVED
PMID: 35577477 (View on PubMed)

Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.

Reference Type DERIVED
PMID: 34921355 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34870800 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33127856 (View on PubMed)

Strand V, Kaine J, Alten R, Wallenstein G, Diehl A, Shi H, Germino R, Murray CW. Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib. Arthritis Res Ther. 2020 Oct 15;22(1):243. doi: 10.1186/s13075-020-02324-7.

Reference Type DERIVED
PMID: 33059710 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32816215 (View on PubMed)

Kivitz AJ, Cohen S, Keystone E, van Vollenhoven RF, Haraoui B, Kaine J, Fan H, Connell CA, Bananis E, Takiya L, Fleischmann R. A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population. Semin Arthritis Rheum. 2018 Dec;48(3):406-415. doi: 10.1016/j.semarthrit.2018.07.006. Epub 2018 Jul 19.

Reference Type DERIVED
PMID: 30177460 (View on PubMed)

Hall S, Nash P, Rischmueller M, Bossingham D, Bird P, Cook N, Witcombe D, Soma K, Kwok K, Thirunavukkarasu K. Tofacitinib, an Oral Janus Kinase Inhibitor: Pooled Efficacy and Safety Analyses in an Australian Rheumatoid Arthritis Population. Rheumatol Ther. 2018 Dec;5(2):383-401. doi: 10.1007/s40744-018-0118-2. Epub 2018 Jun 11.

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PMID: 29949132 (View on PubMed)

Mariette X, Chen C, Biswas P, Kwok K, Boy MG. Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program. Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421. Epub 2018 Apr 2.

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PMID: 28941219 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28143815 (View on PubMed)

Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.

Reference Type DERIVED
PMID: 27889300 (View on PubMed)

Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14.

Reference Type DERIVED
PMID: 26275429 (View on PubMed)

Strand V, Burmester GR, Zerbini CA, Mebus CA, Zwillich SH, Gruben D, Wallenstein GV. Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis: patient-reported outcomes from a phase III trial. Arthritis Care Res (Hoboken). 2015 Apr;67(4):475-83. doi: 10.1002/acr.22453.

Reference Type DERIVED
PMID: 25186034 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25047021 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921032&StudyName=Phase%203%2C%20Randomized%2C%20Double-Blind%2C%20Placebo-Controlled%20Study%20Of%20The%20Safety%20And%20Efficacy%20Of%202%20Doses%20Of%20CP-690%2C550%20In%20Patients%20With%20Active%20Rheumatoid%20Arthritis%20On%20Background%20Methotrexate%20With%20Inadequate%20Response%20To%20TNF%20Inhibitors

To obtain contact information for a study center near you, click here.

Other Identifiers

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A3921032

Identifier Type: -

Identifier Source: org_study_id