NCT01262118

Brief Summary

The purpose of study is to explore the effect of CP-690,550 (tasocitinib) on cholesterol metabolism in patients with active rheumatoid arthritis (RA).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P75+ for phase_1 rheumatoid-arthritis

Timeline
Completed

Started May 2011

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 17, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 23, 2013

Completed
Last Updated

January 23, 2013

Status Verified

December 1, 2012

Enrollment Period

8 months

First QC Date

November 15, 2010

Results QC Date

December 17, 2012

Last Update Submit

December 17, 2012

Conditions

Rheumatoid Arthritis

Keywords

Cholesterol metabolismCholesterol fluxRheumatoid ArthritisTasocitinibCP-690550

Outcome Measures

Primary Outcomes (4)

  • High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline

    Blood level of HDL-C was measured following a 12-hours fasting.

    Baseline

  • High-density Lipoprotein Cholesterol (HDL-C) Concentration at Week 6

    Blood level of HDL-C was measured following a 12-hours fasting.

    Week 6

  • Cholesterol Ester Production Rate at Baseline

    Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.

    Baseline

  • Cholesterol Ester Production Rate at Week 6

    Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.

    Week 6

Secondary Outcomes (7)

  • Low-density Lipoprotein Cholesterol (LDL-C) and Total Cholesterol Concentration

    Baseline, Week 6

  • Cholesterol Ester Fractional Catabolic Rate

    Baseline, Week 6

  • Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Production Rate

    Baseline, Week 6

  • Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Fractional Catabolic Rate

    Baseline, Week 6

  • High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Production Rate

    Baseline, Week 6

  • +2 more secondary outcomes

Study Arms (2)

CP-690,550 (tasocitinib) 10 mg twice daily (BID)

EXPERIMENTAL
Drug: CP-690,550 (tasocitinib)

Healthy Volunteers

NO INTERVENTION

No intervention

Interventions

CP-690,550 (tasocitinib)DRUG

CP-690,550 (tasocitinib) dosed at 10 mg BID for 6 weeks in patients with active rheumatoid arthritis

CP-690,550 (tasocitinib) 10 mg twice daily (BID)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females, 18 years of age or older with active rheumatoid arthritis; Or male and female healthy volunteers 18 years of age and older

You may not qualify if:

  • Pregnant or lactating women
  • Clinically significant systemic disease (other than RA for RA arm)
  • Use of lipid-regulating agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Pfizer Investigational Site

Anniston, Alabama, 36201, United States

Location

Pfizer Investigational Site

Anniston, Alabama, 36207, United States

Location

Pfizer Investigational Site

Little Rock, Arkansas, 72201, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90095, United States

Location

Pfizer Investigational Site

Daytona Beach, Florida, 32114, United States

Location

Pfizer Investigational Site

Ormond Beach, Florida, 32174, United States

Location

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Location

Pfizer Investigational Site

Bingham Farms, Michigan, 48025, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75231, United States

Location

Pfizer Investigational Site

Balatonfüred, 8230, Hungary

Location

Pfizer Investigational Site

Budapest, 1032, Hungary

Location

Related Publications (10)

  • 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: 36931693DERIVED

  • 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: 36601090DERIVED

  • 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: 36600185DERIVED

  • 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: 36526796DERIVED

  • 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: 34870800DERIVED

  • 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: 33127856DERIVED

  • 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: 32816215DERIVED

  • 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: 28143815DERIVED

  • Charles-Schoeman C, Fleischmann R, Davignon J, Schwartz H, Turner SM, Beysen C, Milad M, Hellerstein MK, Luo Z, Kaplan IV, Riese R, Zuckerman A, McInnes IB. Potential mechanisms leading to the abnormal lipid profile in patients with rheumatoid arthritis versus healthy volunteers and reversal by tofacitinib. Arthritis Rheumatol. 2015 Mar;67(3):616-25. doi: 10.1002/art.38974.

    PMID: 25470338DERIVED

  • 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: 25047021DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune 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 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2010

First Posted

December 17, 2010

Study Start

May 1, 2011

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

January 23, 2013

Results First Posted

January 23, 2013

Record last verified: 2012-12

Locations

HU(2)US(9)