Clinical trial NCT00205478: Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The primary endpoint for the study is the ACR20 response at Week 12.
Secondary outcomes:
measure: The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures.
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Medical University - Sofia
city: Sofia
country: Bulgaria
facility: Military Medical Academy - Sofia
city: Sofia
country: Bulgaria
facility: Transport Hospital
city: Stara Zagora
country: Bulgaria
facility: MBAL "Stara Zagora" EAD
city: Opatija
country: Croatia
facility: Thalassotherapia
city: Osijek
country: Croatia
facility: KBC Osijek Ambulanta za bol
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
city: Brno
country: Czech Republic
facility: University Hospital U Sv.Anny
city: Praha 10
country: Czech Republic
facility: University Hospital Kralovske Vinohrady
city: Praha 11
country: Czech Republic
facility: SZZ-Jizni Mesto II
city: Praha 2
country: Czech Republic
facility: Institute of Rheumatology
city: Praha 6
country: Czech Republic
facility: Rheumatology Out-patient Department
city: Beograd
country: Former Serbia and Montenegro
facility: Institute of Rheumatology
city: Niska Banja
country: Former Serbia and Montenegro
facility: Institute of Rheumatology - Niska Banja
city: Zemun
country: Former Serbia and Montenegro
facility: Clinical Center Zemun
city: Bytom
country: Poland
facility: Szpital Specjalistyczny Nr 1
city: Elblag
country: Poland
facility: Wojewodzki Szpital Zespolony
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne
city: Lublin
country: Poland
facility: "Gabinety Profesorow" Prywatna Praktyka
city: Lublin
country: Poland
facility: Instytut Medycyny Wsi im. Witolda Chodzki
city: Sopot
country: Poland
facility: Wojewodzki Zespoￅﾂ Reumatologiczny im.
city: Torun
country: Poland
facility: NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy
city: Wroclaw
country: Poland
facility: Okregowy Szpital Kolejowy
city: Zyrardow
country: Poland
facility: ZOZ Zyrardow
city: Moscow
country: Russian Federation
facility: Pirogov City Clinical Hospital #1
city: Moscow
country: Russian Federation
facility: State Institute of Rheumatology of RAMS
city: Novosibirsk
country: Russian Federation
facility: State Clinical Immunology Research
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Cardiologic
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg Clinical Hospital
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg City Hospital
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg Medical Academy
city: Saratov
country: Russian Federation
facility: Saratov Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: City Pokrovskaya Hospital
city: St. Petersburg
country: Russian Federation
facility: EVIDENCE Clinical and Pharmaceutical Research
city: St. Petersburg
country: Russian Federation
facility: Leningrad Regional Hospital
city: Piestany
country: Slovakia
facility: National Institute of Rheumatic Diseases
city: Ljubljana
country: Slovenia
facility: Clinical Center Ljubljana
city: Dniepropetrovsk
country: Ukraine
facility: Dniepropetrovsk State Medical Academy
city: Donetsk
country: Ukraine
facility: Donetsk State Medical University
city: Kiev
country: Ukraine
facility: Institute of Cardiology of Ukranian AMS
city: Kiev
country: Ukraine
facility: Institute of Gerontology of Ukrainian AMS
city: Kiev
country: Ukraine
facility: SanaClis s.r.o.
city: Zaporizhya
country: Ukraine
facility: Zaporizhya Medical Institute
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Robert Kauffman, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.