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

NCT01204138 | Withdrawn Phase 2

• 1 other identifier: SU-08312010-6811
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Arthritis, Rheumatoid

Keywords

RA, treatment, TNF, cytokines

Outcome Measures

Primary Outcomes (1)

• 20% improvement based on ACR responder criteria

  12 weeks

Secondary Outcomes (1)

• ACR 50/70 and DAS

  12 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

Patient randomized to one of two arms, either placebo, or Apremilast

Drug: Placebo

Apremilast

ACTIVE COMPARATOR

Patients randomized to either placebo or apremilast

Drug: Apremilast

Interventions

Apremilast DRUG

Apremilast 30mg BID

Apremilast

Placebo DRUG

Placebo BID

placebo

Eligibility Criteria

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

You may qualify if:

• Understand and voluntarily sign an informed consent form
• 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:
• 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.

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Stanford University: lead
• Celgene Corporation: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, 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

• Mark Genovese

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 17, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 5, 2016

Record last verified: 2016-02

Locations

US (1)