Active Rheumatoid ArthritisPhase 2NCT00882024
Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA)
A Phase 2 study testing Tranilast in people with Active Rheumatoid Arthritis, run by Nuon Therapeutics, Inc. at 32 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Active Rheumatoid Arthritis
- What is being tested?
- Tranilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 32 sitesin 8 countries
- Study dates
- Mar 2009to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving methotrexate
- Have at least 8 painful/tender and 6 swollen joints
- May be receiving oral steroids, chronic NSAIDs and/or hydroxychloroquine.
Who cannot join
- 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
Trial locations and contacts
32 sites in 8 countries.
32 sites in 8 countries
United States9 sites
Study site
Aventura, Florida
Study site
Duncansville, Pennsylvania
Study site
Frederick, Maryland
Study site
Hickory, North Carolina
Study site
La Jolla, California
Study site
Lansing, Michigan
Study site
Mesa, Arizona
Study site
Paradise Valley, Arizona
Study site
San Diego, California
Germany6 sites
Study site
Hamburg
Study site
Ludwigsfelde
Study site
Naumburg
Study site
Osnabrück
Study site
Ratingen
Study site
Wiesbaden
Argentina4 sites
Study site
Capital Federal, Buenos Aires
Study site
Luján, Buenos Aires
Study site
Quilmes, Buenos Aires
Study site
Rosario, Santa Fe Province
Czechia4 sites
Study site
Brno-Bohunice
Study site
Ostrava-Hlucin
Study site
Prague
Study site
Zlín
Mexico4 sites
Study site
Guadalajara, Jalisco
Study site
Mexicali, Estado de Baja California
Study site
Morelia, Michoacán
Study site
Obregón, Sonora
About this study
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)
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.
Read the 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.
- Conditions
- Active Rheumatoid Arthritis
- Being tested
- Tranilast, Placebo
- Keywords
- Rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TranilastDrug
150 mg tranilast tablets, bid, 12 weeks
TranilastDrug
75 mg tablets, bid, 12 weeks
PlaceboDrug
Placebo tablets, bid, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 Tranilast | Experimental | Tranilast, 300 mg/day Receives: Drug: Tranilast |
| 2 Tranilast | Experimental | Tranilast, 150 mg/day Receives: Drug: Tranilast |
| 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who achieve of ACR20 response
Measured: Week 12
Secondary outcomes (4)
Proportion of subjects achieving ACR 50 and 70 response
Measured: Week 12
EULAR responders (e.g. DAS28 good or moderate responders)
Measured: week 12
Mean change from baseline of each ACR component
Measured: weeks 2, 4, 8, 12 and 16
Assess the safety and tolerability of both doses of tranilast
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuon Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Kitt, MD, Study director, Nuon Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882024
- Sponsor's protocol ID
- A3003RA
- Status last verified
- Jan 2011
- First submitted
- 14 Apr 2009
- Last updated
- 6 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00882024
- Acronym / sponsor ID
- A3003RA
- Conditions
- Active Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Nuon Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Tranilast | Experimental | Drug: TranilastTranilast, 300 mg/day |
| 2 Tranilast | Experimental | Drug: TranilastTranilast, 150 mg/day |
| 3 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Receiving methotrexate
- Have at least 8 painful/tender and 6 swollen joints
- May be receiving oral steroids, chronic NSAIDs and/or hydroxychloroquine.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranilast150 mg tranilast tablets, bid, 12 weeks | Drug | 1 Tranilast |
| Tranilast75 mg tablets, bid, 12 weeks | Drug | 2 Tranilast |
| PlaceboPlacebo tablets, bid, 12 weeks | Drug | 3 |
Primary outcome
Proportion of subjects who achieve of ACR20 response
Time frame: Week 12
4 secondary outcomes
Proportion of subjects achieving ACR 50 and 70 response
Time frame: Week 12
EULAR responders (e.g. DAS28 good or moderate responders)
Time frame: week 12
Mean change from baseline of each ACR component
Time frame: weeks 2, 4, 8, 12 and 16
Assess the safety and tolerability of both doses of tranilast
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2011.
Related trials for Active Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Not yet recruitingPhase 2
Platform Study of Targeted Therapies for Adults With Moderately to Severely Active Rheumatoid Arthritis
Rheumatoid Arthritis
Active, not recruitingObservational study
Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 2
A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)
Active Rheumatoid Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kitt, MD study director
Nuon Therapeutics, Inc.
32 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranilast in people with Active Rheumatoid Arthritis, run by Nuon Therapeutics, Inc. at 32 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Germany, Argentina, Czechia, Mexico and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who achieve of ACR20 response (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2011.