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Arthritis, RheumatoidPhase 2CATARANCT01204138

Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA

A Phase 2 study testing Apremilast in people with Arthritis, Rheumatoid, run by Stanford University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

A Phase II, single institution, double blind, randomized, placebo controlled, cross-over study exploring the safety and efficacy apremilast in patients with active RA with concomitant use of TNF inhibition. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Apremilast
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Sep 2010to Dec 2011
Phase
Phase 2
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Understand and voluntarily sign an informed consent form
  • 18 years of age at the time of signing the informed consent form.
  • Able to adhere to the study visit schedule and other protocol requirements
  • Must have a diagnosis of RA of at least 6 months duration based on the ACR criteria
  • Must have evidence of active disease with DAS-28 > 3.8
  • May be on one of the following DMARDs for at least 12 weeks and at a stable dose for at least 6 weeks:
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  • Methotrexate 7.5-25mg/week
  • Hydroxychloroquine (200-400mg/day)
  • Must be on one of the following SQ TNF inhibitors at a stable, label approved dose for at least 12 weeks:
  • adalimumab (Humira®, Abbott Laboratories, North Chicago, IL)
  • certolizumab pegol (Cimzia®, UCB, Inc, Smyrna, GA)
  • golimumab (Simponi®, Johnson \& Johnson, New Brunswick, NJ)
  • etanercept (Enbrel®, Amgen, Thousand Oaks, CA and Wyeth Pharmaceuticals, Philadelphia, PA)
  • Concommitant use of non-steroidal anti-inflammatory drugs and/or oral corticosteroids (prednisone<10mg/day or equivalent) are permitted if doses have been stable for at least 14 days.
  • If taking methotrexate, patient must also be taking folic or folinic acid at at dose of no less then 5mg/week.
  • Must meet the following laboratory criteria:
  • Hemoglobin > 9 g/dL
  • White blood cell (WBC) count; 3000 /;L (3.0 X 109/L) and 14,000/L (< 14 X 109/L)
  • Platelets; 100,000 /L (100 X 109/L)
  • Serum creatinine; 1.5 mg/dL (or 133mol/L)
  • Total bilirubin; 2.0 mg/dL
  • Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]); 1.5x upper limit of normal (ULN)
  • Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception while on study medication: oral, injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner while on study. A FCBP must agree to have pregnancy tests every 4 weeks while on study medication and for one month after taking the last dose of study medication.
  • Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP while on study medication and for 28 days after taking the last dose of study medication

Who cannot join

  • Inability to provide voluntary consent
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  • Pregnant or breastfeeding
  • Systemic fungal infection
  • Active tuberculosis or a history of incompletely treated tuberculosis
  • History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years)
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  • Clinically significant abnormality on the chest x-ray (CXR) with anteriorposterior and lateral views at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable.
  • Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer)
  • Any clinically significant abnormality on 12-lead ECG at screening
  • History of congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency [CVID])
  • Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
  • History of Human Immunodeficiency Virus (HIV) infection
  • Antibodies to Hepatitis C at screening
  • History of malignancy within 5 years prior to the screening visit (except for treated [i.e. cured] basal cell skin carcinomas and treated [i.e. cured] carcinoma in situ of the cervix)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

A Phase II, single institution, double blind, randomized, placebo controlled, cross-over study exploring the safety and efficacy apremilast in patients with active RA with concomitant use of TNF inhibition. Following a screening period, patients with active disease on stable TNF inhibition will be randomized to receive either apremilast or placebo for a period of 12 weeks. At the end of 12 weeks patients will be assessed for efficacy using the ACR responder index looking for a 20% improvement, then all patients initially randomized and treated in a blinded fashion with apremilast will be crossed over to placebo while those patients initially randomized and treated with placebo will be crossed over to apremilast. Patients will be followed for an additional 12 weeks on treatment to assess both safety and efficacy of this combination treatment. Following 24 weeks of active treatment or early termination, patients will undergo a 28 day safety visit.

Read the detailed description

The primary objective of this study is to evaluate the efficacy of apremilast when used in combination with a background DMARD and TNF inhibition in patients with active RA using the ACR responder index looking for a 20% improvement.

To evaluate the safety and tolerability of apremilast when used in combination with TNF inhibition in patients with active RA.

To evaluate the clinical outcomes in RA using the individual domains of the ACR responder index1 .

To evaluate the clinical outcomes of RA using the Disease Activity Score (DAS28)2 To investigate the effects of apremilast on change in cytokine plasma concentration levels (from baseline to Week 12) and the achievement of an ACR response

Being tested
Apremilast, Placebo
Keywords
RA, treatment, TNF, cytokines
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • ApremilastDrug

    Apremilast 30mg BID

  • PlaceboDrug

    Placebo BID

Study groups in NCT01204138
Study groupRoleWhat they receive
placeboPlacebo comparatorPatient randomized to one of two arms, either placebo, or Apremilast
Receives: Drug: Placebo
ApremilastActive comparatorPatients randomized to either placebo or apremilast
Receives: Drug: Apremilast

What is being measured

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

  1. 20% improvement based on ACR responder criteria

    Measured: 12 weeks

Secondary outcomes (1)

  1. ACR 50/70 and DAS

    Measured: 12 weeks

Timeline

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

  1. First posted17 Sep 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionAug 2011
  4. Study completionDec 2011

Why it stopped: decision of sponsor to withdraw before initiation; 0 patients enrolled

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
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01204138
Sponsor's protocol ID
SU-08312010-6811
Acronym
CATARA
Status last verified
Feb 2016
First submitted
10 Sep 2010
Last updated
5 Feb 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apremilast in people with Arthritis, Rheumatoid, run by Stanford University 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 24 inclusion and 14 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: withdrawn, as of the sponsor's last update on 5 Feb 2016. 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. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

20% improvement based on ACR responder criteria (time frame: 12 weeks). 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 NCT01204138.

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 Feb 2016.

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