Rheumatoid ArthritisPhase 2NCT00205478
Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702
A Phase 2 study testing VX-702 in people with Rheumatoid Arthritis, run by Vertex Pharmaceuticals Incorporated at 43 sites in 9 countries.
Trial summary
The purpose of this study is to assess the clinical activity and safety of two doses of VX-702 compared to placebo in subjects with moderate to severe Rheumatoid Arthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- VX-702
- How many people
- 300 participants
- Where
- 43 sitesin 9 countries
- Study dates
- Jun 2005to Feb 2006
- 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
- Adults with active rheumatoid arthritis for greater than 6 months and evidence of inflammation.
Who cannot join
- Subjects who have conditions precluding the use of cytokine inhibitors or subjects who require DMARDs other than hydroxychloroquine or sulfasalazine are excluded.
Trial locations and contacts
43 sites in 9 countries.
43 sites in 9 countries
Russia11 sites
Pirogov City Clinical Hospital #1
Moscow
State Institute of Rheumatology of RAMS
Moscow
State Clinical Immunology Research
Novosibirsk
Ryazan Regional Clinical Cardiologic
Ryazan
City Pokrovskaya Hospital
Saint Petersburg
EVIDENCE Clinical and Pharmaceutical Research
Saint Petersburg
Leningrad Regional Hospital
Saint Petersburg
Saint Petersburg Clinical Hospital
Saint Petersburg
Saint-Petersburg City Hospital
Saint Petersburg
Saint-Petersburg Medical Academy
Saint Petersburg
Saratov Regional Clinical Hospital
Saratov
Poland9 sites
Szpital Specjalistyczny Nr 1
Bytom
Wojewodzki Szpital Zespolony
Elblag
Malopolskie Centrum Medyczne
Krakow
"Gabinety Profesorow" Prywatna Praktyka
Lublin
Instytut Medycyny Wsi im. Witolda Chodzki
Lublin
Wojewodzki Zespoￅﾂ Reumatologiczny im.
Sopot
NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy
Torun
Okregowy Szpital Kolejowy
Wroclaw
ZOZ Zyrardow
Żyrardów
Ukraine6 sites
Dniepropetrovsk State Medical Academy
Dniepropetrovsk
Donetsk State Medical University
Donetsk
Institute of Cardiology of Ukranian AMS
Kiev
Institute of Gerontology of Ukrainian AMS
Kiev
SanaClis s.r.o.
Kiev
Zaporizhya Medical Institute
Zaporizhya
Czechia5 sites
University Hospital U Sv.Anny
Brno
Institute of Rheumatology
Prague
Rheumatology Out-patient Department
Prague
SZZ-Jizni Mesto II
Prague
University Hospital Kralovske Vinohrady
Prague
Bulgaria4 sites
Medical University - Sofia
Sofia
Military Medical Academy - Sofia
Sofia
Transport Hospital
Sofia
MBAL "Stara Zagora" EAD
Stara Zagora
Croatia3 sites
Thalassotherapia
Opatija
KBC Osijek Ambulanta za bol
Osijek
University Hospital Centre Zagreb
Zagreb
Serbia and Montenegro3 sites
Institute of Rheumatology
Beograd
Institute of Rheumatology - Niska Banja
Niska Banja
Clinical Center Zemun
Zemun
About this study
Official title: A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo Controlled Study of Two Doses of VX-702 in Subjects With Moderate to Severe Rheumatoid Arthritis
The purpose of this study is to assess the clinical activity and safety of two doses of VX-702 compared to placebo in subjects with moderate to severe Rheumatoid Arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- VX-702
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX-702Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint for the study is the ACR20 response at Week 12.
Secondary outcomes (1)
The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Kauffman, MD, PhD, Study director, Vertex Pharmaceuticals Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205478
- Sponsor's protocol ID
- VX04-702-301
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- Last updated
- 7 Dec 2007
- Results posted
- No
Publications
Damjanov N, Kauffman RS, Spencer-Green GT. Efficacy, pharmacodynamics, and safety of VX-702, a novel p38 MAPK inhibitor, in rheumatoid arthritis: results of two randomized, double-blind, placebo-controlled clinical studies. Arthritis Rheum. 2009 May;60(5):1232-41. doi: 10.1002/art.24485.
PubMed 19404957
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo Controlled Study of Two Doses of VX-702 in Subjects With Moderate to Severe Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00205478
- Acronym / sponsor ID
- VX04-702-301
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Study completion
- Feb 2006 (actual)
- First posted
- 20 Sep 2005 (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 assess the clinical activity and safety of two doses of VX-702 compared to placebo in subjects with moderate to severe Rheumatoid Arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with active rheumatoid arthritis for greater than 6 months and evidence of inflammation.
Key exclusion criteria (1 listed)
- Subjects who have conditions precluding the use of cytokine inhibitors or subjects who require DMARDs other than hydroxychloroquine or sulfasalazine are excluded.
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 |
|---|---|---|
| VX-702 | Drug | – |
Primary outcome
The primary endpoint for the study is the ACR20 response at Week 12.
1 secondary outcome
The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures.
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 7 Dec 2007.
- Derived from this study: PubMed 19404957Damjanov N, Kauffman RS, Spencer-Green GT. Efficacy, pharmacodynamics, and safety of VX-702, a novel p38 MAPK inhibitor, in rheumatoid arthritis: results of two randomized, double-blind, placebo-controlled clinical studies. Arthritis Rheum. 2009 May;60(5):1232-41. doi: 10.1002/art.24485.
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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.
Robert Kauffman, MD, PhD study director
Vertex Pharmaceuticals Incorporated
43 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VX-702 in people with Rheumatoid Arthritis, run by Vertex Pharmaceuticals Incorporated at 43 sites in 9 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 1 inclusion and 1 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 7 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Russia, Poland, Ukraine, Czechia, Bulgaria and 4 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. 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?
The primary endpoint for the study is the ACR20 response at Week 12.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00205478, which also lists 1 linked publication.
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 7 Dec 2007.