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

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.

First Received: March 28, 2008 Last Updated: July 17, 2009 History of Changes

Sponsored by:	Nitec Pharma AG
Information provided by:	Nitec Pharma AG
ClinicalTrials.gov Identifier:	NCT00650078

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 tablet formulation of prednisone Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Joint Disorders Rheumatoid Arthritis

Drug Information available for: Prednisone

U.S. FDA Resources

Further study details as provided by Nitec Pharma AG:

Primary Outcome Measures:

ACR 20 response rate [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relative reduction of morning stiffness [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	294
Study Start Date:	March 2008
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: MR tablet formulation of prednisone 1 x 5 mg daily
B: Placebo Comparator	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

Nitec Pharma AG

Investigators

Principal Investigator:

Frank Buttgereit, Prof. Dr.

Charité Campus Mitte, Germany

More Information

No publications provided

Responsible Party:	Nitec Pharma GmbH ( Chief Medical Officer )
Study ID Numbers:	NP01-007, EudraCT-Number: 2007-003508-36
Study First Received:	March 28, 2008
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00650078 History of Changes
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 Nitec Pharma AG:

Signs and Symptoms
Autoimmune Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Predniso(lo)ne

Study placed in the following topic categories:

Anti-Inflammatory Agents
Prednisone
Autoimmune Diseases
Antineoplastic Agents, Hormonal
Joint Diseases
Hormone Antagonists
Arthritis, Rheumatoid
Hormones, Hormone Substitutes, and Hormone Antagonists

Rheumatic Diseases
Glucocorticoids
Hormones
Signs and Symptoms
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Autoimmune Diseases
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Joint Diseases
Physiological Effects of Drugs
Arthritis, Rheumatoid

Hormones, Hormone Substitutes, and Hormone Antagonists
Rheumatic Diseases
Glucocorticoids
Hormones
Pharmacologic Actions
Musculoskeletal Diseases
Therapeutic Uses
Arthritis
Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 11, 2009