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Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00205478
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 7, 2007
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: VX-702 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : June 2005
Actual Study Completion Date : February 2006

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Primary Outcome Measures :
  1. The primary endpoint for the study is the ACR20 response at Week 12.

Secondary Outcome Measures :
  1. The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with active rheumatoid arthritis for greater than 6 months and evidence of inflammation.

Exclusion Criteria:

  • Subjects who have conditions precluding the use of cytokine inhibitors or subjects who require DMARDs other than hydroxychloroquine or sulfasalazine are excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205478


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Locations
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Bulgaria
Medical University - Sofia
Sofia, Bulgaria
Military Medical Academy - Sofia
Sofia, Bulgaria
Transport Hospital
Sofia, Bulgaria
MBAL "Stara Zagora" EAD
Stara Zagora, Bulgaria
Croatia
Thalassotherapia
Opatija, Croatia
KBC Osijek Ambulanta za bol
Osijek, Croatia
University Hospital Centre Zagreb
Zagreb, Croatia
Czech Republic
University Hospital U Sv.Anny
Brno, Czech Republic
University Hospital Kralovske Vinohrady
Praha 10, Czech Republic
SZZ-Jizni Mesto II
Praha 11, Czech Republic
Institute of Rheumatology
Praha 2, Czech Republic
Rheumatology Out-patient Department
Praha 6, Czech Republic
Former Serbia and Montenegro
Institute of Rheumatology
Beograd, Former Serbia and Montenegro
Institute of Rheumatology - Niska Banja
Niska Banja, Former Serbia and Montenegro
Clinical Center Zemun
Zemun, Former Serbia and Montenegro
Poland
Szpital Specjalistyczny Nr 1
Bytom, Poland
Wojewodzki Szpital Zespolony
Elblag, Poland
Malopolskie Centrum Medyczne
Krakow, Poland
"Gabinety Profesorow" Prywatna Praktyka
Lublin, Poland
Instytut Medycyny Wsi im. Witolda Chodzki
Lublin, Poland
Wojewodzki Zespoᅤツ Reumatologiczny im.
Sopot, Poland
NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy
Torun, Poland
Okregowy Szpital Kolejowy
Wroclaw, Poland
ZOZ Zyrardow
Zyrardow, Poland
Russian Federation
Pirogov City Clinical Hospital #1
Moscow, Russian Federation
State Institute of Rheumatology of RAMS
Moscow, Russian Federation
State Clinical Immunology Research
Novosibirsk, Russian Federation
Ryazan Regional Clinical Cardiologic
Ryazan, Russian Federation
Saint Petersburg Clinical Hospital
Saint Petersburg, Russian Federation
Saint-Petersburg City Hospital
Saint-Petersburg, Russian Federation
Saint-Petersburg Medical Academy
Saint-Petersburg, Russian Federation
Saratov Regional Clinical Hospital
Saratov, Russian Federation
City Pokrovskaya Hospital
St. Petersburg, Russian Federation
EVIDENCE Clinical and Pharmaceutical Research
St. Petersburg, Russian Federation
Leningrad Regional Hospital
St. Petersburg, Russian Federation
Slovakia
National Institute of Rheumatic Diseases
Piestany, Slovakia
Slovenia
Clinical Center Ljubljana
Ljubljana, Slovenia
Ukraine
Dniepropetrovsk State Medical Academy
Dniepropetrovsk, Ukraine
Donetsk State Medical University
Donetsk, Ukraine
Institute of Cardiology of Ukranian AMS
Kiev, Ukraine
Institute of Gerontology of Ukrainian AMS
Kiev, Ukraine
SanaClis s.r.o.
Kiev, Ukraine
Zaporizhya Medical Institute
Zaporizhya, Ukraine
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
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Study Director: Robert Kauffman, MD, PhD Vertex Pharmaceuticals Incorporated

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00205478     History of Changes
Other Study ID Numbers: VX04-702-301
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 7, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases