AzTrials
AzTrials

Rheumatoid ArthritisPhase 3NCT02566967

An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve Low Disease Activity (LDA) or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective

A Phase 3 study testing tofacitinib in people with Rheumatoid Arthritis, run by Norman B. Gaylis, MD at 1 site in United States.

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

This study will evaluate the optimal dose of tofacitinib needed to achieve low disease activity (LDA) or clinical remission as measured by the CDAI score. Once LDA or clinical remission has been achieved, the structural benefit in reducing erosions, synovitis and bone edema as measured by low field MRI will be… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
tofacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
May 2015to 20 Mar 2018
Phase
Phase 3
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patient must be at least 18 years old at the screening visit
  • Patient must be able to understand the information provided to them and give written Informed Consent
  • Female subjects of childbearing potential must test negative for pregnancy
  • Male and female subjects of childbearing potential must agree to use two highly effective methods of contraception throughout the study and for at least 3 months after the last dose of tofacitinib.
  • Female patients who are not of childbearing potential must either be postmenopausal for at least 12 months or have undergone a documented hysterectomy and/or bilateral oophorectomy.
  • Patients can be naïve to biologic therapy or have had exposure to TNF or biologic therapy (see appropriate wash out schedule) and be experiencing at least a moderate disease activity score as determined by a CDAI of > 10 at Screening despite currently receiving Methotrexate therapy at a dose of 10-25 mg/weekly for at least 12 weeks and at a stable dose for the past 4 weeks.
Show all 10Show fewer
  • Patients on prednisone must be receiving a daily dose of < 10 mg.
  • Subjects must screen negative for active tuberculosis (TB) by either a PPD or a QuantiFERON Gold test (unless previously performed and documented within 3 months prior to screening). If patient tests positive for latent TB at screening, the chest X-ray at Screening must be negative for active TB and the patient must be started on ( or have completed) an adequate course of therapy for latent tuberculosis at the Baseline visit. Patient must complete the entire 9 month course of treatment for latent TB.
  • Chest radiograph taken at screening (unless taken and documented within 3 months prior to screening) must be negative for active TB and have non clinically significant medical findings.
  • Patients must be able and willing to comply with the requirements of the study protocol

Who cannot join

  • Patients who have a history of any inflammatory disease which would be interfere with outcome measurement
  • Patients who in the Investigator's opinion have a medical condition in which participation in this trial is contraindicated
  • Patients who have received intramuscular, intravenous, or intraarticular (IM/IV/IA) corticosteroids 28 days prior to baseline.
  • Patients who have active TB or a history of active TB (positive PPD skin test >5mm and a positive chest x-Ray) or patients who have come in close contact with an individual with active TB.
  • Patients with a history of acute or chronic viral hepatitis B or C or those who test positive at screening.
  • Patients with a known human immunodeficiency virus (HIV) infection.
Show all 19Show fewer
  • Concurrent malignancy or a history of malignancy other than a non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
  • Patients who have a metal device affected by MRI (e.g. any type of electronic, mechanical or magnetic implant; cardiac pacemaker; aneurysm clip(s); implanted cardioverter defibrillator; or cochlear implant)
  • Patients who have potential ferromagnetic foreign body (metal slivers metal shavings, other metal objects) for which they have sought medical attention
  • Patients at a high risk of infection in the Investigator's opinion or have had recurrent infections requiring hospitalization or parenteral antimicrobial therapy within the past 6 months.
  • Patients with an adverse reaction to tofacitinib
  • Patients with any other condition (e.g., clinically significant laboratory values) which in the Investigator's judgment would make the patient unsuitable for inclusion in this study
  • Patients who have received prohibited medications:
  • the following approved biological therapy for RA: etanercept, adalimumab, anakinra, abatacept, tocilizumab within 28 days of baseline
  • rituximab within 9 months of baseline
  • infliximab within 56 days of baseline
  • DMARDs other than methotrexate within 28 days of baseline
  • any experimental biologic agent within three months or 5 half-lives prior to baseline
  • exposure to JAK inhibitor 14. Female patients who are breast-feeding, pregnant, or plan to become pregnant during the trial or within twelve weeks following last dose of study drug

Trial locations and contacts

1 site in 1 country.

United States1 site

  • AARDS Research, Inc.

    Aventura, Florida, 33180

Other trials in United States

About this study

Official title: An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve LDA or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective When Treating to Target

This study will evaluate the optimal dose of tofacitinib needed to achieve low disease activity (LDA) or clinical remission as measured by the CDAI score. Once LDA or clinical remission has been achieved, the structural benefit in reducing erosions, synovitis and bone edema as measured by low field MRI will be determined at the same time period by the use of the OMERACT/RAMRIS scoring system

Read the detailed description

This study will evaluate the optimal dose of tofacitinib needed to achieve low disease activity (LDA) or clinical remission as measured by the CDAI score. Once LDA or clinical remission has been achieved, the structural benefit in reducing erosions, synovitis and bone edema as measured by low field MRI will be determined at the same time period by the use of the OMERACT/RAMRIS scoring system and correlated to the clinical findings. The target for each patient will be determined at the time of study entry depending on the degree of disease activity of the individual patient. This is based on the understanding that LDA is an acceptable goal in certain patients with long standing disease or high disease activity. If the patient reaches LDA while taking tofacitinib at a 5 mg b.i.d. dose, the patient will be given the opportunity to have the dose increased to 10 mg b.i.d. in the hopes of reaching clinical remission.

There are two treat to target goals: Clinical Remission as defined by a CDAI score of <2.8 for those patients who entered the study with a CDAI score of <22 and Low Disease Activity (LDA) as defined by a CDAI score of <10 for those who entered the study with a CDAI score of > 22.

Being tested
tofacitinib
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • tofacitinibDrug

    oral tofacitinib will be taken 2 times daily

Study groups in NCT02566967
Study groupRoleWhat they receive
open labelOtheropen label use of tofacitinib at either 5 mg bid or 10 mg bid delending on treat to target goal
Receives: Drug: tofacitinib

What is being measured

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

  1. Record the optimal dose of tofacitinib needed to achieve LDA or clinical remission as measured by CDAI score

    the daily dosed used in patients to achieve LDA

    Measured: one year

Secondary outcomes (7)

  1. low -field (0.3T) MRI will be used to measure the reduction of synovitis and bone edema

    was synovitis, bone edema and erosion reduced

    Measured: one year

  2. correlation of the structural and clinical responses performed the structural outcomes as measured by MERERACT and correlate them to the clinical responses and dose adjustments made during the course of the study

    was there a correlation is structural and clinical response

    Measured: one year

  3. record the number of patients who reach low disease activity and a measurable structural response

    the number of patient who reached LDA and a measurable structural change

    Measured: one year

  4. record the number of patients in which structural response occurred without clinical response

    number of patients who had a structural response but no clinical response

    Measured: one year

  5. record the number of patients who required an increase in the dose of tofacitinib due to lack of clinical response from Baseline as measured by CDAI score

    number of patients who had dose escalated to 10 mg bid

    Measured: one year

  6. record the change in CDAI score for all patients from Baseline through the last dose of the initial dose (5 mg b.i.d) of tofacitinib

    record CDAI scores from Baseline to Week 52

    Measured: one year

  7. record the change in CDAI score from the step up period ( 10 mg b.i.d) to the end of the dosing period

    record CDAI score at dose 10 mg bid

    Measured: one year

Timeline

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

  1. First posted2 Oct 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionDec 2017
  4. Study completion20 Mar 2018

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02566967
Sponsor's protocol ID
RA-012015
Status last verified
Jan 2017
First submitted
1 Oct 2015
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tofacitinib in people with Rheumatoid Arthritis, run by Norman B. Gaylis, MD at 1 site in United States.

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 10 inclusion and 19 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Record the optimal dose of tofacitinib needed to achieve LDA or clinical remission as measured by CDAI score (time frame: one year). 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 NCT02566967.

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 5 Jul 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in