Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA)

• Sponsor: Nuon Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00882024
• Collaborator: (none)
• Enrollment: 250
• Locations: 32
• Arms: 3
• Duration (Months): 21
• Patients Per Site: 7.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate whether tranilast at two different dosages compared to placebo is effective in patients with active RA when added to continuing methotrexate (MTX) therapy.

Condition or Disease	Intervention/Treatment	Phase
Active Rheumatoid Arthritis	Drug: Tranilast; Drug: Tranilast; Drug: Placebo	Phase 2

Detailed Description

The primary objective of this study is to assess the efficacy and safety of two different doses of tranilast as determined by ACR20 response at 12 weeks.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast With Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients With Active Rheumatoid Arthritis (RA)
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Tranilast Tranilast, 300 mg/day	Drug: Tranilast; 150 mg tranilast tablets, bid, 12 weeks
Experimental: 2 Tranilast Tranilast, 150 mg/day	Drug: Tranilast; 75 mg tablets, bid, 12 weeks
Placebo Comparator: 3 Placebo	Drug: Placebo; Placebo tablets, bid, 12 weeks

Outcome Measures

Primary Outcome Measures

1. Proportion of subjects who achieve of ACR20 response [Week 12]

Secondary Outcome Measures

1. Proportion of subjects achieving ACR 50 and 70 response [Week 12]

2. EULAR responders (e.g. DAS28 good or moderate responders) [week 12]

3. Mean change from baseline of each ACR component [weeks 2, 4, 8, 12 and 16]

4. Assess the safety and tolerability of both doses of tranilast [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Receiving methotrexate

• Have at least 8 painful/tender and 6 swollen joints

• May be receiving oral steroids, chronic NSAIDs and/or hydroxychloroquine.

Exclusion Criteria:

• Use of any anti-arthritic treatments except those allowed in inclusion criteria

• Pregnant or nursing females

• Abnormal laboratory values

• History of clinically significant renal, hepatic dysfunction, psychiatric disorder, or alcohol/drug dependence

• Clinically significant systemic infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Mesa	Arizona	United States
2		Paradise Valley	Arizona	United States
3		La Jolla	California	United States
4		San Diego	California	United States
5		Aventura	Florida	United States
6		Frederick	Maryland	United States
7		Lansing	Michigan	United States
8		Hickory	North Carolina	United States
9		Duncansville	Pennsylvania	United States
10		Capital Federal	Buenos Aires	Argentina
11		Lujan	Buenos Aires	Argentina
12		Quilmes	Buenos Aires	Argentina
13		Rosario	Santa Fe	Argentina
14		Plovdiv		Bulgaria
15		Sofia		Bulgaria
16		Brno-Bohunice		Czech Republic
17		Ostrava-Hlucin		Czech Republic
18		Praha		Czech Republic
19		Zlin		Czech Republic
20		Hamburg		Germany
21		Ludwigsfelde		Germany
22		Naumberg		Germany
23		Osnabruck		Germany
24		Ratingen		Germany
25		Wiesbaden		Germany
26		Mexicali	Baja California	Mexico
27		Guadalajara	Jalisco	Mexico
28		Morelia	Michoacan	Mexico
29		Obregon	Sonora	Mexico
30		Belgrade		Serbia
31		Niska Banja		Serbia
32		London		United Kingdom

Sponsors and Collaborators

• Nuon Therapeutics, Inc.

Investigators

• Study Director: Michael Kitt, MD, Nuon Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00882024
• Other Study ID Numbers: A3003RA
• First Posted: Apr 16, 2009
• Last Update Posted: Jan 6, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: Rheumatoid arthritis
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Tranilast

Study Results

No Results Posted as of Jan 6, 2011