A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

NCT00853385 | Completed Phase 3 Results DMC

• 1 other identifier: A3921064
• Study Type: interventional
• Target: 717
• Locations: 21 countries
• Sites: 125

Brief Summary

This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also included.

Conditions

Rheumatoid Arthritis

Keywords

oral DMARD; JAK inhibitor; clinical trial

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6

  ACR20 response: greater than or equal to (\>=) 20% improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

  Month 6

• Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3

  HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.

  Baseline, Month 3

• Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6

  DAS28-4 (ESR) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (\<=) 3.2 implied low disease activity and \> 3.2 to 5.1 implied moderate to high disease activity, and \< 2.6 = remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

  Month 6

Secondary Outcomes (42)

• Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3

  Month 1, 3

• Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12

  Month 9, 12

• Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6

  Month 1, 3, 6

• Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12

  Month 9, 12

• Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6

  Month 1, 3, 6

Study Arms (5)

5mg

EXPERIMENTAL

Drug: CP 690,550

10 mg

EXPERIMENTAL

Drug: CP-690,550

Placebo Sequence 1

PLACEBO COMPARATOR

Other: Placebo

Placebo Sequence 2

PLACEBO COMPARATOR

Other: Placebo

adalimumab

ACTIVE COMPARATOR

Biological: Biologic TNFi

Interventions

CP 690,550 DRUG

tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months

5mg

CP-690,550 DRUG

tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months

10 mg

Placebo OTHER

placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months

Placebo Sequence 1

Biologic TNFi BIOLOGICAL

placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months

Also known as: Humira (Adalimumab)

adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
• The patient must have had an inadequate response to methotrexate and have active disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) \>28 mm in the local laboratory. 2. CRP \>7 mg/L in the central laboratory.
• No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
• The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.

You may not qualify if:

• Blood dyscrasias including confirmed: 1. Hemoglobin \<9 g/dL or Hematocrit \<30%; 2. White blood cell count \<3,000 cu.mm. Absolute neutrophil count \<1,200 cu.mm; 4. Platelet count \<100,000/L
• History of any other autoimmune rheumatic disease other than Sjogren's syndrome
• No malignancy or history of malignancy.
• History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
• Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.
• Patients who have previously received adalimumab therapy for any reason.
• Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.
• Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure

Sponsors & Collaborators

• Pfizer: lead

Study Sites (125)

Pfizer Investigational Site

Gilbert, Arizona, 85234, United States

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Pfizer Investigational Site

Glendale, Arizona, 85304, United States

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Mesa, Arizona, 85202, United States

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Paradise Valley, Arizona, 85253, United States

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Phoenix, Arizona, 85037, United States

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Jonesboro, Arkansas, 72401, United States

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Fair Oaks, California, 95628, United States

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San Diego, California, 92108, United States

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Boulder, Colorado, 80304, United States

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Largo, Florida, 33777, United States

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Naples, Florida, 34102, United States

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Palm Harbor, Florida, 34684, United States

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Pinellas Park, Florida, 33782, United States

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Plantation, Florida, 33324, United States

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St. Petersburg, Florida, 33710, United States

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Tampa, Florida, 33613, United States

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Decatur, Georgia, 30033, United States

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Marietta, Georgia, 30060, United States

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Rockford, Illinois, 61107, United States

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Evansville, Indiana, 47714, United States

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Wichita, Kansas, 67203, United States

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Lexington, Kentucky, 40504, United States

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Lexington, Kentucky, 40515, United States

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Baton Rouge, Louisiana, 70809, United States

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Haverhill, Massachusetts, 01830, United States

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Worcester, Massachusetts, 01610, United States

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Grand Rapids, Michigan, 49546, United States

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Cincinnati, Ohio, 45219, United States

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Oklahoma City, Oklahoma, 73112, United States

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Greenville, South Carolina, 29601, United States

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Austin, Texas, 78705, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77034, United States

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Lubbock, Texas, 79424, United States

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Mesquite, Texas, 75150, United States

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Seattle, Washington, 98104, United States

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Seattle, Washington, 98122, United States

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Clarksburg, West Virginia, 26301, United States

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St Leonards, New South Wales, 2065, Australia

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Cairns, Queensland, 4870, Australia

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Maroochydore, Queensland, 4558, Australia

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Malvern East, Victoria, 3145, Australia

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Sarajevo, 71000, Bosnia and Herzegovina

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Pleven, 5800, Bulgaria

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Plovdiv, 4000, Bulgaria

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Plovdiv, 4002, Bulgaria

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Sevlievo, 5400, Bulgaria

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Sofia, 1606, Bulgaria

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Sofia, 1709, Bulgaria

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Vancouver, British Columbia, V5Z 1L7, Canada

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Lunenburg, Nova Scotia, B0J 2C0, Canada

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London, Ontario, N6A 4V2, Canada

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Mississauga, Ontario, L5M 2V8, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Québec, Quebec, G1W 4R4, Canada

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Trois-Rivières, Quebec, G8Z 1Y2, Canada

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Saskatoon, Saskatchewan, S7N 0W8, Canada

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Rancagua, Región del Libertador General Bernardo O’Higgins, 2841959, Chile

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Santiago, RM, 7510186, Chile

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Santiago, RM, 8360156, Chile

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Providencia, Santiago, RM, 7530206, Chile

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Cartago, Cartago Province, Costa Rica

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San José, Provincia de San José, 00, Costa Rica

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San José, Provincia de San José, Costa Rica

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Osijek, 31000, Croatia

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Split, 21000, Croatia

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Zagreb, 10000, Croatia

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Brno, 60200, Czechia

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Brno, 656 91, Czechia

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Brno, 65691, Czechia

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Brno-Židenice, 615 00, Czechia

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Hlučín, 748 01, Czechia

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Pardubice, 530 02, Czechia

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Prague, 128 50, Czechia

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Prague, 140 00, Czechia

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Prague, 14800, Czechia

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Praha 11 - Chodov, 148 00, Czechia

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Zlín, 760 01, Czechia

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Frederiksberg, 2000, Denmark

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Randers NOE, 8930, Denmark

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Santo Domingo, Santo Domingo Province, 00000, Dominican Republic

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Hyvinkää, 05800, Finland

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Aachen, 52064, Germany

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Berlin, 14059, Germany

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Frankfurt am Main, 60590, Germany

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Halle, 06108, Germany

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Halle, 06128, Germany

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Herne, 44652, Germany

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Ratingen, 40882, Germany

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Würzburg, 97080, Germany

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Guadalajara, Jalisco, 44620, Mexico

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Mexico City, Mexico City, 10700, Mexico

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Morelia, Michoacán, 58249, Mexico

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San Luis Potosí City, San Luis Potosí, 78240, Mexico

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Lipa City, Batangas, 4217, Philippines

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Angeles City, Pampanga, 2009, Philippines

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Cebu City, 6000, Philippines

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Bialystok, 15-337, Poland

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Cieszyn, 43-400, Poland

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Kościan, 64-000, Poland

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Krakow, 31-501, Poland

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Sopot, 81-759, Poland

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Torun, 87-100, Poland

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Warsaw, 02-118, Poland

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Bratislava, 82606, Slovakia

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Dunajská Streda, 92901, Slovakia

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Košice, 040 01, Slovakia

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Nové Zámky, 94001, Slovakia

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Povazska Dystrica, 017 01, Slovakia

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Žilina, 010 01, Slovakia

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Pfizer Investigational Site

Daegu, 705-718, South Korea

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Gwangju, 501-757, South Korea

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Seoul, 110-744, South Korea

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Seoul, 133-792, South Korea

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A Coruña, A Coruña, 15006, Spain

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Santiago de Compostela, A Coruña, 15705, Spain

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Madrid, Madrid, 28041, Spain

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Vigo, Pontevedra, 36200, Spain

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Seville, Sevilla, 41009, Spain

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Valencia, Valencia, 46026, Spain

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Rajathevee, Bangkok, 10400, Thailand

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Pfizer Investigational Site

Amphoe Muang, Chiang Mai, 50200, Thailand

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Metropolitan Borough of Wirral, Merseyside, CH49 5PE, United Kingdom

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Pfizer Investigational Site

Cannock, Staffs, WS11 2XY, United Kingdom

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Pfizer Investigational Site

Dudley, West Midlands, DY1 2HQ, United Kingdom

Location

Related Publications (26)

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• 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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• 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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• 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.

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• 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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• 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.

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• Bartlett SJ, Bingham CO, van Vollenhoven R, Murray C, Gruben D, Gold DA, Cella D. The impact of tofacitinib on fatigue, sleep, and health-related quality of life in patients with rheumatoid arthritis: a post hoc analysis of data from Phase 3 trials. Arthritis Res Ther. 2022 Apr 5;24(1):83. doi: 10.1186/s13075-022-02724-x.

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• 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.

  PMID: 34921355 DERIVED

• 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.

  PMID: 34870800 DERIVED

• Bergman M, Tundia N, Yang M, Orvis E, Clewell J, Bensimon A. Economic Benefit from Improvements in Quality of Life with Upadacitinib: Comparisons with Tofacitinib and Methotrexate in Patients with Rheumatoid Arthritis. Adv Ther. 2021 Dec;38(12):5649-5661. doi: 10.1007/s12325-021-01930-4. Epub 2021 Oct 12.

  PMID: 34636000 DERIVED

• 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.

  PMID: 33127856 DERIVED

• 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.

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  PMID: 32816215 DERIVED

• 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.

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• van Vollenhoven RF, Lee EB, Fallon L, Zwillich SH, Wilkinson B, Chapman D, DeMasi R, Keystone E. Tofacitinib in Rheumatoid Arthritis: Lack of Early Change in Disease Activity and the Probability of Achieving Low Disease Activity at Month 6. Arthritis Care Res (Hoboken). 2019 Jan;71(1):71-79. doi: 10.1002/acr.23585.

  PMID: 29696833 DERIVED

• 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.

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• 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.

  PMID: 26275429 DERIVED

• 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.

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  PMID: 22873531 DERIVED

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinib; Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 2, 2009
• Study Start: May 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: January 18, 2013
• Results First Posted: January 9, 2013

Record last verified: 2013-01

Locations

BO (1); CA (8); DO (1); SL (6); KR (4); FI (1); DE (8); PH (3); AU (4); TH (2); CR (3); ME (4); ES (6); BU (6); CZ (11); DK (2); PL (7); CO (3); GB (3); US (38); CL (4)