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Completed

NCT Number: NCT00650078

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research and Arthritis Centre, Windsor, Ontario, Canada

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About this study

Study with completed results acquired from Horizon in 2024.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MR Prednisone

Drug

1 x 5 mg daily

Placebo

Drug

1x daily

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Acronym: CAPRA-2

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 1, 2008
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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