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

Tracking Information

First Received Date ^ICMJE

March 28, 2008

Last Updated Date

July 17, 2009

Start Date ^ICMJE

March 2008

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00650078 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized Multi-Center, Double-Blind, Placebo-Controlled Study of a New Modified-Release Tablet Formulation of Prednisone (Lodotra®) in Patients With Rheumatoid Arthritis

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Drug: MR tablet formulation of prednisone
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

294

Completion Date

July 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Germany, Hungary, Poland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00650078

Responsible Party

Chief Medical Officer, Nitec Pharma GmbH

Study ID Numbers ^ICMJE

NP01-007, EudraCT-Number: 2007-003508-36

Study Sponsor ^ICMJE

Nitec Pharma AG

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Frank Buttgereit, Prof. Dr.

Charité Campus Mitte, Germany

Information Provided By

Nitec Pharma AG

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP