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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)

This study has been completed.
Information provided by (Responsible Party):
Horizon Pharma Ireland, Ltd., Dublin Ireland Identifier:
First received: March 28, 2008
Last updated: April 23, 2013
Last verified: April 2013
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
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

Resource links provided by NLM:

Further study details as provided by Horizon Pharma Ireland, Ltd., Dublin Ireland:

Primary Outcome Measures:
  • 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:
  • 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).

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00650078

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Horizon Pharma Ireland, Ltd., Dublin Ireland 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

Keywords provided by Horizon Pharma Ireland, Ltd., Dublin Ireland:
Signs and Symptoms
Autoimmune Diseases
Joint Diseases
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on September 20, 2017