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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT01204138
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    Apremilast 30mg BID
  • Placebo — DRUG
    Placebo BID

Study Details

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.

Key Dates

First listed
Sep 17, 2010
Start date
Sep 30, 2010
Status verified
Feb 2016
Primary completion
Aug 31, 2011
Completion
Dec 31, 2011

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: placebo
    Patient randomized to one of two arms, either placebo, or Apremilast
  • Active Comparator: Apremilast
    Patients randomized to either placebo or apremilast

Primary Outcome Measure

20% improvement based on ACR responder criteria [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305-

Find similar trials in Stanford, CA

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Stanford University School of Medicine· Stanford, CA

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