A 12-week Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis

• Sponsor: Vertex Pharmaceuticals Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01052194
• Collaborator: (none)
• Enrollment: 206
• Locations: 48
• Arms: 5
• Duration (Months): 16.9
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study is designed to evaluate safety and assess initial efficacy of VX-509, a JAK3 inhibitor, for treatment of subjects with active RA. This study will assess the clinical response of 4 doses of VX-509 compared to placebo when administered for 12 weeks to patients with active RA. The study will also evaluate the safety and tolerability of VX-509 compared to placebo when administered for 12 weeks to subjects with active RA.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Placebo; Drug: VX-509; Drug: VX-509; Drug: VX-509; Drug: VX-509	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 206 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A 12-week, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 25 mg b.i.d. VX-509	Drug: VX-509; tablets, 25mg b.i.d. for 12 weeks
Experimental: 50 mg b.i.d. VX-509	Drug: VX-509; tablet, 50 mg b.i.d. for 12 weeks
Experimental: 100 mg b.i.d. VX-509	Drug: VX-509; tablet, 100 mg b.i.d. for 12 weeks
Experimental: 150 mg b.i.d. VX-509	Drug: VX-509; tablet, 150 mg b.i.d. for 12 weeks
Placebo Comparator: Placebo	Drug: Placebo; tablet, placebo b.i.d. for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Proportion of subjects who achieve an ACR20 response [Week 12]

2. Change from baseline in DAS28 [Week 12]

Secondary Outcome Measures

1. Proportion of subjects who achieve an ACR50,70 response [Week 12]

2. Proportion of subjects who achieve moderate or good EULAR response [Week 12]

3. Magnitude of improvement in the components of the ACR response criteria [Week 12]

4. Pharmacokinetics of VX-509 [Week 6]

5. Pharmacodynamics (PD) of biomarker responses [Week 6]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All subjects must have been diagnosed with RA as defined by the ACR revised criteria with disease duration of at least 6 months from confirmed diagnosis

• Subjects must have a swollen joint count of ≥6 out of 28 joints and tender joint count of ≥6 out of 28 joints. Joints that have had prior surgery are to be excluded from the joint count.

• Baseline CRP level must be 1.5 times greater than the upper limit of normal at Screening.

• Subjects must have failed at least 1 nonbiologic DMARD for any reason.

• Subjects may have previously failed no more than 1 biologic DMARD and discontinued treatment for reasons other than inadequate response. Subjects must not have been treated with Rituximab previously.

• Subjects must be willing to comply with contraception requirements.

Exclusion Criteria:

• Subjects with inflammatory rheumatological disorders other than RA.

• History or evidence of a clinically significant disorder other than RA (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric disorders), condition or disease that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

• Subjects with clinically important abnormalities in screening physical examination or in screening laboratory test results (including the presence of either hepatitis B surface antigen, hepatitis C virus antibody, or HIV types 1 -- Subjects with elevation in alanine aminotransferase or aspartate aminotransferase above the upper limit of normal.

• History of hematologic disorders including neutropenia and thrombocytopenia.

• Subjects with an acute or chronic active infection requiring systemic antimicrobial treatment, or subjects who are at high risk of developing an infection due to a compromised immune system. Antifungals for onychomycosis or low-dose antibiotics for rosacea, that are not inhibitors or inducers of CYP3A, will be allowed.

• Subjects who require concomitant use of any inhibitors or inducers of cytochrome P450 (CYP) 3A.

• Subjects who have been treated with intra-articular injections of corticosteroids within 28 days prior to Day 1.

• Subjects who have planned major surgery (e.g., joint replacement) or any procedures during the study.

• Have received any live, attenuated vaccinations within 1 month prior to study drug administration.

• History of drug or alcohol abuse or excessive alcohol as determined by the investigator, during the last 12 months before the screening visit.

• History of TB infection of any kind (pulmonary or extrapulmonary, active or latent), regardless of history of anti-TB treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States	35216
2		Huntsville	Alabama	United States	35801
3		Peoria	Arizona	United States	85381
4		La Mesa	California	United States	97942
5		Trumbull	Connecticut	United States	06611
6		Tampa	Florida	United States	33612
7		Tampa	Florida	United States	33614
8		Venice	Florida	United States	34292
9		Decatur	Georgia	United States	30033
10		Worcester	Massachusetts	United States	01610
11		St. Louis	Missouri	United States	63141
12		Charlotte	North Carolina	United States	28210
13		Oklahoma City	Oklahoma	United States	73104
14		Duncansville	Pennsylvania	United States	16635
15		Charleston	South Carolina	United States	29406
16		Dallas	Texas	United States	75235
17		Spokane	Washington	United States	99204
18		Clarksburg	West Virginia	United States	26301
19		Antwerpen		Belgium
20		Karlovac		Croatia
21		Opatija		Croatia
22		Zagreb		Croatia
23		Erfurt		Germany
24		Frankfurt		Germany
25		Hamburg		Germany
26		Hildesheim		Germany
27		Nauheim		Germany
28		Zerbst		Germany
29		Balatonfured		Hungary
30		Budapest		Hungary
31		Debrecen		Hungary
32		Veszprem		Hungary
33		Elblag		Poland
34		Limanow		Poland
35		Lublin		Poland
36		Wroclaw		Poland
37		San Juan		Puerto Rico
38		Baia Mare		Romania
39		Braila		Romania
40		Bucharest		Romania
41		Galati		Romania
42		Kemerovo		Russian Federation
43		Novosibirsk		Russian Federation
44		Ryazan		Russian Federation
45		Vladimir		Russian Federation
46		Voronezh		Russian Federation
47		Belgrade		Serbia
48		Niska Banja		Serbia

Sponsors and Collaborators

• Vertex Pharmaceuticals Incorporated

Investigators

• Study Director: Medical Monitor, Vertex Pharmaceuticals Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vertex Pharmaceuticals Incorporated
• ClinicalTrials.gov Identifier: NCT01052194
• Other Study ID Numbers: VX09-509-101; 2009-017438-32
• First Posted: Jan 20, 2010
• Last Update Posted: Dec 13, 2012
• Last Verified: Dec 1, 2012

• Keywords provided by Vertex Pharmaceuticals Incorporated: Rheumatoid Arthritis
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Dec 13, 2012