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Rheumatoid ArthritisPhase 2NCT01359150

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

A Phase 2 study testing CP-690,550 in people with Rheumatoid Arthritis, run by Pfizer at 57 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
CP-690,550
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
223 participants
Where
57 sitesin 2 countries
Study dates
Sep 2011to Feb 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

57 sites in 2 countries.

57 sites in 2 countries

United States51 sites

  • Pfizer Investigational Site

    Albany, New York, 12206

  • Pfizer Investigational Site

    Austin, Texas, 78705

  • Pfizer Investigational Site

    Bethlehem, Pennsylvania, 18015

  • Pfizer Investigational Site

    Bingham Farms, Michigan, 48025

  • Pfizer Investigational Site

    Binghamton, New York, 13905

  • Pfizer Investigational Site

    Boulder, Colorado, 80304

  • Pfizer Investigational Site

    Charlotte, North Carolina, 28210

  • Pfizer Investigational Site

    Clarksburg, West Virginia, 26301

  • Pfizer Investigational Site

    Columbia, Missouri, 65203

  • Pfizer Investigational Site

    Columbia, Missouri, 65212

  • Pfizer Investigational Site

    Cumberland, Maryland, 21502

  • Pfizer Investigational Site

    Dallas, Texas, 75231

  • Pfizer Investigational Site

    Dayton, Ohio, 45417

  • Pfizer Investigational Site

    Duncansville, Pennsylvania, 16635

  • Pfizer Investigational Site

    Edina, Minnesota, 55435

  • Pfizer Investigational Site

    Fair Oaks, California, 95628

  • Pfizer Investigational Site

    Gilbert, Arizona, 85234

  • Pfizer Investigational Site

    Greenville, South Carolina, 29601

  • Pfizer Investigational Site

    Jacksonville, Florida, 32216

  • Pfizer Investigational Site

    Jonesboro, Arkansas, 72401

  • Pfizer Investigational Site

    Knoxville, Tennessee, 37909

  • Pfizer Investigational Site

    Lebanon, New Hampshire, 03756

  • Pfizer Investigational Site

    Leominster, Massachusetts, 01453

  • Pfizer Investigational Site

    Lexington, Kentucky, 40504

  • Pfizer Investigational Site

    Los Angeles, California, 90095

  • Pfizer Investigational Site

    Mesquite, Texas, 75150

  • Pfizer Investigational Site

    Minot, North Dakota, 58701

  • Pfizer Investigational Site

    Morton Grove, Illinois, 60053

  • Pfizer Investigational Site

    Naples, Florida, 34102

  • Pfizer Investigational Site

    New Port Richey, Florida, 34652

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73112

  • Pfizer Investigational Site

    Olean, New York, 14760

  • Pfizer Investigational Site

    Paradise Valley, Arizona, 85253

  • Pfizer Investigational Site

    Port Richey, Florida, 34668

  • Pfizer Investigational Site

    Rochester, New York, 14618

  • Pfizer Investigational Site

    Rockford, Illinois, 61107

  • Pfizer Investigational Site

    Rocky Mount, North Carolina, 27804

  • Pfizer Investigational Site

    Roseville, California, 95661

  • Pfizer Investigational Site

    Seattle, Washington, 98104

  • Pfizer Investigational Site

    Seattle, Washington, 98122

  • Pfizer Investigational Site

    Tacoma, Washington, 98405

  • Pfizer Investigational Site

    Tampa, Florida, 33613

  • Pfizer Investigational Site

    Trumbull, Connecticut, 06611

  • Pfizer Investigational Site

    Upland, California, 91786

  • Pfizer Investigational Site

    Vancouver, Washington, 98664

  • Pfizer Investigational Site

    Vernon Hills, Illinois, 60061

  • Pfizer Investigational Site

    Wichita, Kansas, 67208

  • Pfizer Investigational Site

    Worcester, Massachusetts, 01605

  • Pfizer Investigational Site

    Worcester, Massachusetts, 01608

  • Pfizer Investigational Site

    Wyomissing, Pennsylvania, 19610

  • Pfizer Investigational Site

    Zephyrhills, Florida, 33542

Other trials in United States

Poland6 sites

  • Pfizer Investigational Site

    Cieszyn, 43-400

  • Pfizer Investigational Site

    Kościan, 64-000

  • Pfizer Investigational Site

    Poznan, 60-773

  • Pfizer Investigational Site

    Torun, 87-100

  • Pfizer Investigational Site

    Warsaw, 02-256

  • Pfizer Investigational Site

    Wroclaw, 50-088

Other trials in Poland

About this study

Official title: 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 Or Placebo Cp-690,550 With And Without Background Methotrexate

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

Being tested
CP-690,550, placebo
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CP-690,550Drug

    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).

  • placeboDrug

    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

Study groups in NCT01359150
Study groupRoleWhat they receive
Treatment Group 1: 10 mg BID CP-690,550 (100 subjects).ExperimentalCP-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.
Receives: Drug: CP-690,550
Treatment Group 2:Placebo CP-690,550 (100 subjects).Placebo comparatorPlacebo 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.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 64 (End of Study [EOS])

  2. 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.

    Measured: Day 64 (EOS)

Secondary outcomes (7)

  1. Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens

    Response to the pneumococcal vaccine (seroconversion) was defined as >= 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in each of the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.

    Measured: Day 64 (EOS)

  2. Percentage of Participants Who Responded to Each of the 3 Influenza Antigens

    Response to the influenza vaccine (seroconversion) was defined as >= 4 fold increase in antibody titers from vaccination baseline (Day 29) in each of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.

    Measured: Day 64 (EOS)

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

    Seroprotection was defined as achieving protective antibody titers to the influenza vaccine as measured by a hemagglutination inhibition (HAI) assay titer of >= 1:40 in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.

    Measured: Day 64 (EOS)

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

    Geometric mean fold rises (GMFRs) for the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. Confidence intervals (CIs) for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.

    Measured: Day 64 (EOS)

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

    GMFRs for the 3 influenza antigens (B, H1N1, H3N2) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.

    Measured: Day 64 (EOS)

  6. Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody

    Antibody geometric mean concentration (GMC) for 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated.

    Measured: Day 64 (EOS)

  7. Geometric Mean Titer (GMT) of Anti-Influenza Antibody

    Antibody geometric mean titer (GMT) for 3 influenza antigens antigens (B, H1N1, H3N2) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMT and corresponding 2-sided 95% confidence intervals (CI) were evaluated.

    Measured: Day 64 (EOS)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01359150
Sponsor's protocol ID
A3921129
Status last verified
Feb 2013
First submitted
11 May 2011
Last updated
29 Mar 2013
Data monitoring committee
Yes

Publications

  • Wright G, Mysler E, Roberts KD, Shelbaya A, Sweet L, Masri KR. Impact of the Sociodemographic Index on Efficacy/Safety of Tofacitinib in Patients with Rheumatoid Arthritis: Post Hoc Analysis of Phase 2/3/3b/4 Studies. Rheumatol Ther. 2026 Oct 16. doi: 10.1007/s40744-026-00881-y. Online ahead of print.

    PubMed 42888330

  • 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.

    PubMed 39192350

  • 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.

    PubMed 38958913

  • 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.

    PubMed 36931693

  • 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.

    PubMed 36601090

  • 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.

    PubMed 36600185

  • 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.

    PubMed 36526796

  • 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.

    PubMed 34870800

  • 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.

    PubMed 33127856

  • 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.

    PubMed 32816215

  • 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.

    PubMed 28143815

  • 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.

    PubMed 25795907

  • 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.

    PubMed 25047021

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CP-690,550 in people with Rheumatoid Arthritis, run by Pfizer at 57 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64) (time frame: Day 64 (End of Study [EOS])). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01359150, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2013.

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