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Rheumatoid ArthritisPhase 2NCT01250548

The Controlled Trial of Apremilast for Rheumatoid Arthritis Treatment (CARAT)

A Phase 2 study testing apremilast in people with Rheumatoid Arthritis, run by Baylor Research Institute 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
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Trial summary

The purpose of this study is to compare the effects of apremilast with a placebo (an inactive substance that looks like apremilast) on you and other people with rheumatoid arthritis. 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?
apremilast
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteUnited States
Study dates
May 2010to Jun 2014
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

  • Must be able to adhere to the study visit schedule and other protocol requirements
  • documented rheumatoid arthritis (RA) diagnosis by the 1987 American College of Rheumatology (ACR) criteria for at least 6 months
  • disease duration 6 or more months (from symptom onset)
  • failed 1 or more DMARD
  • active RA despite current DMARD therapy; active disease defined as 4 or more tender and 4 or more swollen joints (out of 28 joints examined) and any one of the following:
  • ESR 28 or higher mm/hr;
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  • CRP 1.0 or more mg/dl;
  • Morning stiffness 45 or more minutes.
  • Patients receiving DMARD or biologic therapy must undergo a drug washout.
  • Patients receiving a nonsteroidal anti-inflammatory drug (NSAID) and/or prednisone (10 or less mg day) must be on stable doses of these agents for more than 2 weeks.
  • Must meet laboratory criteria as specified in the protocol
  • Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening and must adhere to adequate forms of contraception as defined in the protocol. Must agree to pregnancy tests every 28 days while on study medication.
  • Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in 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
  • History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, neurologic, gastrointestinal, immunologic, or other major diseases
  • 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 female
  • Systemic fungal infection
  • Active tuberculosis (TB) or a history of incompletely treated tuberculosis.
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  • History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years)
  • Clinically significant abnormality on the chest x-ray (CXR) at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable.
  • Use of any investigational medication within 28 days prior to randomization or 5 half-lives if known (whichever is longer)
  • Any clinically significant abnormality on 12-lead ECG at screening
  • History of congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency [CVID])
  • History of Human Immunodeficiency Virus (HIV) infection
  • Presence of hepatitis B surface antigens (HBsAg) or Hepatitis core antibody positive at screening.
  • Antibodies to Hepatitis C virus 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)
  • currently on DMARD therapy
  • currently taking biologics
  • treated with rituximab in the last 6 months
  • Recent hospitalization (last 3 months)
  • Planned pregnancy or major surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baylor Research Institute - Arthritis Care and Research Center

    Dallas, Texas, 75231

Other trials in United States

About this study

Official title: The Controlled Trial of Apremilast for Rheumatoid Arthritis Treatment

The purpose of this study is to compare the effects of apremilast with a placebo (an inactive substance that looks like apremilast) on you and other people with rheumatoid arthritis.

The investigators will be collecting information in this study to help us determine -

  • the safety of apremilast in patients with active rheumatoid arthritis
  • how long it takes for patients with active rheumatoid arthritis to respond to apremilast
  • how long the effects of apremilast last after the treatment has ended.
Read the detailed description

Many manifestations associated with RA result from, or are significantly influenced by, the effects of pro-inflammatory cytokines (e.g., TNF, IL-1, IL-6). Specific inhibition of these cytokines with newer, parenterally administered biologic agents has revolutionized the treatment of RA. Apremilast is a novel, orally administered drug which approaches the reduction of pro-inflammatory cytokines via inhibition of phosphodiesterase type 4 (PDE4).

Apremilast, Acetamide, N-[2-[ (1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl) ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl] is a phosphodiesterase type 4 (PDE4) inhibitor under development for use in the treatment of inflammatory conditions.

PDE4 is one of the major phosphodiesterases expressed in leukocytes. Inhibitors of PDE4 cause accumulation of intracellular cyclic adenosine monophosphate (cAMP), which in turn activates protein kinase A and other downstream effectors, resulting in inhibition of pro-inflammatory cytokine transcription and other cellular responses such as neutrophil degranulation, chemotaxis, and adhesion to endothelial cells.

In human cellular models, apremilast inhibited production of inflammatory mediators such as TNF-α, IL-12, IL-2, IFN-γ, IL-5, IL-8, leukotriene B4 (LTB4), and the adhesion molecule CD18/CD11b (Mac-1).

Apremilast has also been shown to be a potent anti-inflammatory agent in several animal models of inflammation.

Being tested
apremilast, Placebo
Keywords
Rheumatoid arthritis, RA, Active rheumatoid arthritis
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • apremilastBiological

    30 mg BID apremilast taken orally for the first 12 weeks followed by responders randomized to either 30 mg BID apremilast (oral) or 30 mg BID placebo (oral) for 8 weeks

  • PlaceboOther

Study groups in NCT01250548
Study groupRoleWhat they receive
2Active comparatorNot described
Receives: Biological: apremilast
ApremilastPlacebo comparatorPlacebo Compared to apremilast arm
Receives: Other: Placebo

What is being measured

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

  1. To determine the time to response for subjects with active RA taking apremilast (30 mg per os [PO], twice per day [BID])

    Measured: 1.5 years

Secondary outcomes (3)

  1. Determine time to flare when apremilast is withdrawn

    Measured: 1.5 years

  2. Assess the efficacy and magnitude of response to apremilast in active RA measured by ACR 20, 50, & 70 response rates

    Measured: 2 years

  3. Assess safety of apremilast in subjects with active RA

    Review of labs and possible adverse effects of study drug including Data Safety Monitoring Committee analysis.

    Measured: 2 years

Timeline

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

  1. First posted1 Dec 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJun 2014
  4. Study completionJun 2014

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01250548
Sponsor's protocol ID
009-293
Status last verified
Sep 2014
First submitted
26 Aug 2010
Last updated
3 Sep 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing apremilast in people with Rheumatoid Arthritis, run by Baylor Research Institute 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 13 inclusion and 20 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 3 Sep 2014. 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 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?

To determine the time to response for subjects with active RA taking apremilast (30 mg per os [PO], twice per day [BID]) (time frame: 1.5 years). 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 NCT01250548.

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 3 Sep 2014.

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