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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205478
• Other study ID #: VX04-702-301
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: December 5, 2007
• Start date: June 2005
• Est. completion date: February 2006

Study information

• Verified date: December 2007
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of HealthCzech Republic: State Institute for Drug ControlSlovakia: State Institute for Drug ControlSlovenia: Agency for Medicinal Products - Ministry of HealthCroatia: Ministry of Health and Social CareSerbia and Montenegro: Agency for Drugs and Medicinal DevicesBulgaria: Bulgarian Drug AgencyRussia: Pharmacological Committee, Ministry of HealthUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• VX-702

Locations

Country	Name	City	State
Bulgaria	Medical University - Sofia	Sofia
Bulgaria	Military Medical Academy - Sofia	Sofia
Bulgaria	Transport Hospital	Sofia
Bulgaria	MBAL "Stara Zagora" EAD	Stara Zagora
Croatia	Thalassotherapia	Opatija
Croatia	KBC Osijek Ambulanta za bol	Osijek
Croatia	University Hospital Centre Zagreb	Zagreb
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
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
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 Zespo?? Reumatologiczny im.	Sopot
Poland	NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy	Torun
Poland	Okregowy Szpital Kolejowy	Wroclaw
Poland	ZOZ Zyrardow	Zyrardow
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
Slovakia	National Institute of Rheumatic Diseases	Piestany
Slovenia	Clinical Center Ljubljana	Ljubljana
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

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Countries where clinical trial is conducted

Bulgaria,  Croatia,  Czech Republic,  Former Serbia and Montenegro,  Poland,  Russian Federation,  Slovakia,  Slovenia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint for the study is the ACR20 response at Week 12.
Secondary	The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures.