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

NCT01250548 | Completed Phase 2 DMC

• 1 other identifier: 009-293
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; RA; Active rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

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

  1.5 years

Secondary Outcomes (3)

• Determine time to flare when apremilast is withdrawn

  1.5 years

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

  2 years

• Assess safety of apremilast in subjects with active RA

  2 years

Study Arms (2)

2

ACTIVE COMPARATOR

Biological: apremilast

Apremilast

PLACEBO COMPARATOR

Placebo Compared to apremilast arm

Other: Placebo

Interventions

apremilast BIOLOGICAL

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

2

Placebo OTHER

Apremilast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Research Institute - Arthritis Care and Research Center

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

apremilast

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• John Cush, MD

  Baylor Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: December 1, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 3, 2014

Record last verified: 2014-09

Locations

US (1)