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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Horizon Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00650078
First received: March 28, 2008
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: MR prednisone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Horizon Pharma, Inc.:

Primary Outcome Measures:
  • ACR 20 Response Rate at Visit 4 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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:
  • Relative Reduction of Morning Stiffness [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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).


Enrollment: 350
Study Start Date: March 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NP01
Modified Release (MR) prednisone 5 mg
Drug: MR prednisone
1 x 5 mg daily
Placebo Comparator: Placebo Drug: Placebo
1x daily

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650078

  Show 52 Study Locations
Sponsors and Collaborators
Horizon Pharma, Inc.
Investigators
Principal Investigator: Frank Buttgereit, Prof. Dr. Charité Campus Mitte, Germany
  More Information

No publications provided

Responsible Party: Horizon Pharma, Inc.
ClinicalTrials.gov Identifier: NCT00650078     History of Changes
Other Study ID Numbers: NP01-007, EudraCT-Number: 2007-003508-36
Study First Received: March 28, 2008
Results First Received: November 1, 2012
Last Updated: April 23, 2013
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Canada: Health Canada

Keywords provided by Horizon Pharma, Inc.:
Signs and Symptoms
Autoimmune Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Predniso(lo)ne

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014