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Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis (CAPRA-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00650078
Recruitment Status : Completed
First Posted : April 1, 2008
Results First Posted : December 13, 2012
Last Update Posted : April 30, 2013
Sponsor:
Information provided by (Responsible Party):
Horizon Pharma Ireland, Ltd., Dublin Ireland

Study Description
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Brief Summary:
The purpose of the study is to compare the safety and efficacy, with regards to the signs and symptoms, of MR prednisone (Lodotra®) versus placebo in combination with standard Disease Modifying Anti-Rheumatic Drug (DMARD) treatment in patients with active rheumatoid arthritis.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: MR prednisone Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Multi-Center, Double-Blind, Placebo-Controlled Study of a New Modified-Release Tablet Formulation of Prednisone (Lodotra®) in Patients With Rheumatoid Arthritis
Study Start Date : March 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arms and Interventions
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Arm Intervention/treatment
Experimental: NP01
Modified Release (MR) prednisone 5 mg
 Drug: MR prednisone
1 x 5 mg daily
Placebo Comparator: Placebo Drug: Placebo
1x daily


Outcome Measures
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Primary Outcome Measures :
  1. ACR 20 Response Rate at Visit 4 [ Time Frame: Week 12 ]

    Responders were defined as patients whose improvement from baseline to Visit 4 (Week 12) fulfilled all 3 of the following criteria:

    • > 20% reduction in the tender joint count (0-28)
    • > 20% reduction in the swollen joint count (0-28)

    • > 20% reduction in 3 out of the 5 following additional measures:

      • Patient's assessment of pain
      • Patient's global assessment of disease activity
      • Physician's global assessment of disease activity
      • Functional Disability Index of the Health Assessment Questionnaire
      • C-reactive protein or erythrocyte sedimentation rate


Secondary Outcome Measures :
  1. Relative Reduction of Morning Stiffness [ Time Frame: Week 12 ]
    Data for the duration of morning stiffness were obtained from patient diaries. Duration of morning stiffness was the difference between the time of resolution of morning stiffness and the time of wake-up. Duration of morning stiffness is the average of the morning stiffness duration (minutes) over the last 7 days prior to visit day (including day of visit). If more than 4 assessments were missing, then the duration was set to missing. Baseline was the value recorded at Week -1 (Visit 0).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented history of RA in agreement with ACR criteria
  • DMARD treatment for RA greater than or equal to 6 months, with a stable dose greater than or equal to 6 weeks prior to screening visit
  • Duration of morning stiffness greater than or equal to 45 minutes
  • greater than or equal to 4 swollen joints (out of 28)
  • greater than or equal to 4 tender joints (out of 28)

Exclusion Criteria:

  • Suffering from another disease, which requires glucocorticoid treatment during the study period
  • Synovectomy within 4 months prior to study start

  • Use of glucocorticoids:

    • Continued use of systemic glucocorticoids within 4 weeks prior to screening visit
    • Intermittent use of glucocorticoids within 2 weeks prior to screening visit.
    • Joint injections within 6 weeks prior to screening visit
    • Topical glucocorticoids must be stopped at screening visit
  • Use of biologicals such as: tumor necrosis factor α (TNFα) inhibitors and other compounds within 5 serum half lives prior to screening visit
  • Pregnancy or nursing
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00650078


Locations
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Sponsors and Collaborators
Horizon Pharma Ireland, Ltd., Dublin Ireland
Investigators
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Principal Investigator: Frank Buttgereit, Prof. Dr. Charité Campus Mitte, Germany
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Horizon Pharma Ireland, Ltd., Dublin Ireland
ClinicalTrials.gov Identifier: NCT00650078    
Other Study ID Numbers: NP01-007
EudraCT-Number: 2007-003508-36
First Posted: April 1, 2008    Key Record Dates
Results First Posted: December 13, 2012
Last Update Posted: April 30, 2013
Last Verified: April 2013
Keywords provided by Horizon Pharma Ireland, Ltd., Dublin Ireland:
Signs and Symptoms
Autoimmune Diseases
Joint Diseases
Arthritis
 Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Predniso(lo)ne
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents