A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or Placebo

NCT01359150 | Completed Phase 2 Results DMC

• 1 other identifier: A3921129
• Study Type: interventional
• Target: 223
• Locations: 2 countries
• Sites: 57

Brief Summary

A Randomized, Double Blind, Placebo Controlled Phase 2 Study To assess the Immune Response Following Administration of Influenza and Pneumococcal Vaccines to Subjects with Rheumatoid Arthritis receiving CP-690,550 with and Without background Methotrexate

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64)

  Satisfactory humoral response to the pneumococcal vaccine was defined as greater than or equal to (\>=) 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in at least 6 of 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.

  Day 64 (End of Study [EOS])

• Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64)

  Satisfactory humoral response to the influenza vaccine was defined as \>= 4 fold increase in antibody titers from vaccination baseline (Day 29) in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.

  Day 64 (EOS)

Secondary Outcomes (7)

• Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens

  Day 64 (EOS)

• Percentage of Participants Who Responded to Each of the 3 Influenza Antigens

  Day 64 (EOS)

• Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine

  Day 64 (EOS)

• Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29)

  Day 64 (EOS)

• Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29)

  Day 64 (EOS)

Study Arms (2)

Treatment Group 1: 10 mg BID CP-690,550 (100 subjects).

EXPERIMENTAL

CP-690,550 will be administered for 4 weeks, vaccines will be administered at week 4. CP-690,550 will then continue for another 5 weeks at which point the immune response will be evaluated.

Drug: CP-690,550

Treatment Group 2:Placebo CP-690,550 (100 subjects).

PLACEBO COMPARATOR

Placebo will be administered for 4 weeks, vaccines will be administered at week 4. Placebo will then continue for another 5 weeks at which point the immune response will be evaluated.

Drug: placebo

Interventions

CP-690,550 DRUG

Treatment Group 1: 10 mg BID CP-690,550 (100 subjects). Strata 1: 10 mg BID CP-690,550 on background methotrexate (50 subjects); Strata 2: 10 mg BID CP-690,550 monotherapy (50 subjects).

Treatment Group 1: 10 mg BID CP-690,550 (100 subjects).

placebo DRUG

Placebo CP-690,550 (100 subjects). Strata 1: Placebo CP-690,550 on background methotrexate (50 subjects); Strata 2: Placebo CP-690,550 monotherapy (50 subjects). Influenza and pneumococcal vaccines will be administered to all subjects

Treatment Group 2:Placebo CP-690,550 (100 subjects).

Eligibility Criteria

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

You may qualify if:

• The subject must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of RA by satisfying at least four of the seven criteria.
• The subject must have active disease at both screening and baseline

You may not qualify if:

• History of any documented influenza or pneumococcal infection within the last 3 months.
• Receipt of any vaccine within 1 month prior to the initial study drug administration (CP-690,550 or placebo CP-690,550).
• If a subject has received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of initial study drug administration.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (57)

Pfizer Investigational Site

Gilbert, Arizona, 85234, United States

Location

Pfizer Investigational Site

Paradise Valley, Arizona, 85253, United States

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Pfizer Investigational Site

Jonesboro, Arkansas, 72401, United States

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Pfizer Investigational Site

Fair Oaks, California, 95628, United States

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Los Angeles, California, 90095, United States

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Pfizer Investigational Site

Roseville, California, 95661, United States

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Pfizer Investigational Site

Upland, California, 91786, United States

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Boulder, Colorado, 80304, United States

Location

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Trumbull, Connecticut, 06611, United States

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Jacksonville, Florida, 32216, United States

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Naples, Florida, 34102, United States

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New Port Richey, Florida, 34652, United States

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Port Richey, Florida, 34668, United States

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Tampa, Florida, 33613, United States

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Zephyrhills, Florida, 33542, United States

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Morton Grove, Illinois, 60053, United States

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Rockford, Illinois, 61107, United States

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Pfizer Investigational Site

Vernon Hills, Illinois, 60061, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67208, United States

Location

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Lexington, Kentucky, 40504, United States

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Cumberland, Maryland, 21502, United States

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Pfizer Investigational Site

Leominster, Massachusetts, 01453, United States

Location

Pfizer Investigational Site

Worcester, Massachusetts, 01605, United States

Location

Pfizer Investigational Site

Worcester, Massachusetts, 01608, United States

Location

Pfizer Investigational Site

Bingham Farms, Michigan, 48025, United States

Location

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Edina, Minnesota, 55435, United States

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Pfizer Investigational Site

Columbia, Missouri, 65203, United States

Location

Pfizer Investigational Site

Columbia, Missouri, 65212, United States

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Pfizer Investigational Site

Lebanon, New Hampshire, 03756, United States

Location

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Albany, New York, 12206, United States

Location

Pfizer Investigational Site

Binghamton, New York, 13905, United States

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Pfizer Investigational Site

Olean, New York, 14760, United States

Location

Pfizer Investigational Site

Rochester, New York, 14618, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28210, United States

Location

Pfizer Investigational Site

Rocky Mount, North Carolina, 27804, United States

Location

Pfizer Investigational Site

Minot, North Dakota, 58701, United States

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Dayton, Ohio, 45417, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73112, United States

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Pfizer Investigational Site

Bethlehem, Pennsylvania, 18015, United States

Location

Pfizer Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

Pfizer Investigational Site

Wyomissing, Pennsylvania, 19610, United States

Location

Pfizer Investigational Site

Greenville, South Carolina, 29601, United States

Location

Pfizer Investigational Site

Knoxville, Tennessee, 37909, United States

Location

Pfizer Investigational Site

Austin, Texas, 78705, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75231, United States

Location

Pfizer Investigational Site

Mesquite, Texas, 75150, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98104, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98122, United States

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Pfizer Investigational Site

Tacoma, Washington, 98405, United States

Location

Pfizer Investigational Site

Vancouver, Washington, 98664, United States

Location

Pfizer Investigational Site

Clarksburg, West Virginia, 26301, United States

Location

Pfizer Investigational Site

Cieszyn, 43-400, Poland

Location

Pfizer Investigational Site

Kościan, 64-000, Poland

Location

Pfizer Investigational Site

Poznan, 60-773, Poland

Location

Pfizer Investigational Site

Torun, 87-100, Poland

Location

Pfizer Investigational Site

Warsaw, 02-256, Poland

Location

Pfizer Investigational Site

Wroclaw, 50-088, Poland

Location

Related Publications (12)

• 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.

  PMID: 39192350 DERIVED

• 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.

  PMID: 38958913 DERIVED

• 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.

  PMID: 36931693 DERIVED

• 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.

  PMID: 36601090 DERIVED

• 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.

  PMID: 36600185 DERIVED

• 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.

  PMID: 36526796 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

• 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

• 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.

  PMID: 32816215 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.

  PMID: 28143815 DERIVED

• Winthrop KL, Silverfield J, Racewicz A, Neal J, Lee EB, Hrycaj P, Gomez-Reino J, Soma K, Mebus C, Wilkinson B, Hodge J, Fan H, Wang T, Bingham CO 3rd. The effect of tofacitinib on pneumococcal and influenza vaccine responses in rheumatoid arthritis. Ann Rheum Dis. 2016 Apr;75(4):687-95. doi: 10.1136/annrheumdis-2014-207191. Epub 2015 Mar 20.

  PMID: 25795907 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.

  PMID: 25047021 DERIVED

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

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

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 24, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 29, 2013
• Results First Posted: March 29, 2013

Record last verified: 2013-02

Locations

US (51); PL (6)