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Rheumatoid ArthritisPhase 2NCT01059864

Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550

A Phase 2 study testing CP-690,550 and Atorvastatin in people with Rheumatoid Arthritis, run by Pfizer at 15 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

All patients will be in instructed to eat a therapeutic lifestyle diet and will receive CP-690,550 throughout the 12 weeks of this study. After 6 weeks, half will receive the cholesterol lowering agent, atorvastatin, and half a matching placebo. 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 and Atorvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
111 participants
Where
15 sitesin 2 countries
Study dates
Feb 2010to Nov 2010
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

  • must be diagnosed as having active rheumatoid arthritis
  • agree to participate in the study and sign and informed consent document

Who cannot join

  • History of serious infection within the past 6 months
  • test positive for TB
  • have any uncontrolled clinically significant disease or laboratory tests
  • require administration of prohibited medications during the study

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

United States10 sites

  • Pfizer Investigational Site

    Allen, Texas, 75013

  • Pfizer Investigational Site

    Birmingham, Alabama, 35209

  • Pfizer Investigational Site

    Dayton, Ohio, 45417

  • Pfizer Investigational Site

    Gilbert, Arizona, 85234

  • Pfizer Investigational Site

    Greenville, South Carolina, 29601

  • Pfizer Investigational Site

    Huntsville, Alabama, 35801

  • Pfizer Investigational Site

    Jacksonville, Florida, 32216

  • Pfizer Investigational Site

    Mayfield Village, Ohio, 44143

  • Pfizer Investigational Site

    Scottsdale, Arizona, 85251

  • Pfizer Investigational Site

    Upland, California, 91786

Other trials in United States

South Korea5 sites

  • Pfizer Investigational Site

    Seoul, 110-744

  • Pfizer Investigational Site

    Seoul, 120-752

  • Pfizer Investigational Site

    Seoul, 133-792

  • Pfizer Investigational Site

    Seoul, 137-701

  • Pfizer Investigational Site

    Seoul, 143-729

Other trials in South Korea

About this study

Official title: Phase 2 Study Of The Effects Of Open-Label CP-690,550 And Double-Blind Atorvastatin On Lipids In Patients With Active Rheumatoid Arthritis

All patients will be in instructed to eat a therapeutic lifestyle diet and will receive CP-690,550 throughout the 12 weeks of this study. After 6 weeks, half will receive the cholesterol lowering agent, atorvastatin, and half a matching placebo. This study will first measure the effects of CP-690,550 on cholesterol levels and then the effects of adding atorvastatin on those levels.

Being tested
CP-690,550, Atorvastatin, Atorvastatin Placebo
Keywords
cholesterol, lipids, rheumatoid arthritis, CP-690, 550
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

    12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12

  • AtorvastatinDrug

    Starting at Week 6 and continuing through Week 12 atorvastatin 10 mg oral tablets administered once daily

  • CP-690,550Drug

    12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12

  • Atorvastatin PlaceboDrug

    Starting at Week 6 and continuing through Week 12 atorvastatin placebo tablets administered once daily

Study groups in NCT01059864
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: CP-690,550; Drug: Atorvastatin
Arm 2ExperimentalNot described
Receives: Drug: CP-690,550; Drug: Atorvastatin Placebo

What is being measured

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

  1. Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12

    Measured: Baseline (Week 6), Week 12

Secondary outcomes (20)

  1. Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12

    Measured: Baseline (Week 6), Week 12

  2. 12-Hours Fasting Lipid Profile

    Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: LDL-C, high-density lipoprotein-cholesterol (HDL-C), very low density lipoprotein-cholesterol (VLDL-C), total cholesterol, apolipoprotein A-1, apolipoprotein B, triglycerides (TGs) and Non-HDL-C.

    Measured: Day 0, Week 2, 6 (Baseline), 10, 12

  3. 12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins

    Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: plasma lipoprotein VLDL-C, LDL-C and HDL-C particles size.

    Measured: Day 0, Week 2, 6 (Baseline), 10, 12

  4. 12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles

    Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: total and large VLDL-C and chylomicron particles (VLDLCP), medium and small VLDL-C particles; total, large, medium and small LDL-C particles; and intermediate density lipoprotein (IDL).

    Measured: Day 0, Week 2, 6 (Baseline), 10, 12

  5. 12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles

    Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: total, large, medium and small HDL-C particles.

    Measured: Day 0, Week 2, 6 (Baseline), 10, 12

  6. Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])

    DAS28-3 (CRP) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count and the CRP (milligram per liter [mg/L]). DAS28-3 (CRP) less than or equal to (<=)3.2 indicated low disease activity, DAS28-3 (CRP) more than (>) 3.2 to 5.1 indicated moderate to high disease activity.

    Measured: Day 0, Week 6 (Baseline), 12

  7. Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])

    DAS28-4 (CRP) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, C-reactive protein (CRP) [mg/L] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-4 [CRP] <=3.2 indicated low disease activity, DAS28-4 [CRP] >3.2 to 5.1 indicated moderate to high disease activity and DAS28 less than 2.6 indicates remission.

    Measured: Day 0, Week 6 (Baseline), 12

  8. Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])

    DAS28-3 (ESR) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). DAS28-3 (ESR) <=3.2 indicated low disease activity, DAS28-3 (ESR) >3.2 to 5.1 indicated moderate to high disease activity.

    Measured: Day 0, Week 6 (Baseline), 12

  9. Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])

    DAS28-4 (ESR) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) [mm/hr] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging from 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-4 (ESR) <=3.2 indicated low disease activity, DAS28-4 (ESR) >3.2 to 5.1 indicated moderate to high disease activity.

    Measured: Day 0, Week 6 (Baseline), 12

  10. Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response

    ACR20 responses were defined as greater than or equal to 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.

    Measured: Week 6 (Baseline), 12

  11. Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

    ACR50 responses were defined as greater than or equal to 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.

    Measured: Week 6 (Baseline), 12

  12. Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

    ACR70 responses were defined as greater than or equal to 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.

    Measured: Week 6 (Baseline), 12

  13. Tender-Joint Count

    Tender joint count (TJC) is an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (for artificial joints).

    Measured: Day 0, Week 6 (Baseline), 12

  14. Swollen-Joint Count

    Swollen joint count (SJC): an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling using the following scale: Present/Absent/Not Done/Not Applicable (for artificial joints).

    Measured: Day 0, Week 6 (Baseline), Week 12

  15. C-Reactive Protein (CRP)

    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. Normal range is 1-3 milligram per liter (mg/L).

    Measured: Day 0, Week 6 (Baseline), 12

  16. Erythrocyte Sedimentation Rate (ESR)

    ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.

    Measured: Day 0, Week 6 (Baseline), 12

  17. Patient Assessment of Arthritis Pain

    Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.

    Measured: Day 0, Week 6 (Baseline), 12

  18. Physician's Global Assessment (PhysGA) of Arthritis Pain

    The physician evaluated participants disease signs, functional capacity and physical examination independent of the patient's global assessment of arthritis. Physician's response was recorded using 0-100 mm visual analog scale (VAS), where 0=no pain and 100=most severe pain.

    Measured: Day 0, Week 6 (Baseline), Week 12

  19. Patient's Global Assessment (PtGA) of Arthritis Pain

    Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0-100 mm visual analog scale where 0=no pain and 100=most severe pain.

    Measured: Day 0, Week 6 (Baseline), Week 12

  20. Health Assessment Questionnaire Disability Index (HAQ-DI)

    HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.

    Measured: Day 0, Week 6 (Baseline), 12

Timeline

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

  1. First posted1 Feb 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionNov 2010
  4. Study completionNov 2010

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01059864
Sponsor's protocol ID
A3921109
Status last verified
Nov 2012
First submitted
28 Jan 2010
Last updated
13 Dec 2012
Data monitoring committee
Yes

Publications

  • 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

  • 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.

    PubMed 37453736

  • 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

  • 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

  • McInnes IB, Kim HY, Lee SH, Mandel D, Song YW, Connell CA, Luo Z, Brosnan MJ, Zuckerman A, Zwillich SH, Bradley JD. Open-label tofacitinib and double-blind atorvastatin in rheumatoid arthritis patients: a randomised study. Ann Rheum Dis. 2014 Jan;73(1):124-31. doi: 10.1136/annrheumdis-2012-202442. Epub 2013 Mar 12.

    PubMed 23482473

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CP-690,550 and Atorvastatin in people with Rheumatoid Arthritis, run by Pfizer at 15 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 4 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 13 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, South Korea. 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. 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 13 Dec 2012). 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?

Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12 (time frame: Baseline (Week 6), Week 12). 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 NCT01059864, which also lists 12 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 13 Dec 2012.

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