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

History of Changes

Results First Received: November 1, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Rheumatoid Arthritis
Interventions:	Drug: MR prednisone Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Approximately 350 patients were to be enrolled (at screening, Visit 0), with a minimum of 6 and a maximum of 28 patients at each center. It was planned to randomize (at Visit 1) a total of 294 patients in 50-55 centers in North America and Europe (Germany, Hungary, Poland and UK). First patient enrolled March, 2008; last patient contact May, 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a 1 week screening phase followed by a 12 week double blind treatment phase. In addition to their standard RA medication, patients received placebo during the 1 week screening phase. The purpose of the screening phase was to establish the patient's compliance with study medication and completion of diary entries.

Reporting Groups

	Description
NP01	Modified Release (MR) prednisone 5 mg
Placebo	No text entered.

Participant Flow: Overall Study

	NP01	Placebo
STARTED	231	119
COMPLETED	217	106
NOT COMPLETED	14	13

Baseline Characteristics

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Reporting Groups

	Description
NP01	Modified Release (MR) prednisone 5 mg
Placebo	No text entered.
Total	Total of all reporting groups

Baseline Measures

	NP01	Placebo	Total
Number of Participants [units: participants]	231	119	350
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	186	95	281
>=65 years	45	24	69
Age [units: years] Mean ± Standard Deviation	57.1 ± 9.89	57.5 ± 9.55	57.2 ± 9.76
Gender [units: participants]
Female	192	102	294
Male	39	17	56
Region of Enrollment [units: participants]
United States	48	27	75
Hungary	67	35	102
Canada	8	5	13
Poland	98	47	145
Germany	1	2	3
United Kingdom	9	3	12

Outcome Measures

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1. Primary:

ACR 20 Response Rate at Visit 4 [ Time Frame: Week 12 ]

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2. Secondary:

Relative Reduction of Morning Stiffness [ Time Frame: Week 12 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The first publication shall be the presentation of a joint, multicenter publication of the Study results. If such a multicenter publication is not submitted within 24 months after conclusion of the Study at all sites, INSTITUTION/INVESTIGATOR may publish the results from the INSTITUTION’S site individually, provided that it is submitted to SPONSOR for review and comment 60 days prior to submission for publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Senior Vice President, Clinical Development & Operations
Organization: Horizon Pharma
phone: 224-383-3012
e-mail: agrahn@horizonpharma.com

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

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