A Clinical Trial to look at the Safety, Tolerability and Efficacy of the Drug Product GS-9876 on patients with Rheumatoid Arthritis who are also being treated with Methotrexate.
- Conditions
- Rheumatoid ArthritisMedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2016-001496-75-PL
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
1) Active RA disease as defined by: a TJC of = 6 (out of 68), an SJC of = 6 (out of 66) at Screening and Day 1
2) Inadequate response to treatment with oral or parenteral MTX 7.5 to 25 mg/week continuously for at least 12 weeks, with at least 6 weeks at a stable dose (defined as no change in prescription) prior to the first dose of study drug
3) Subjects must be receiving a folic or folinic acid supplementation at a stable dose. Subjects who are not taking folic or folinic acid at Screening should be initiated on an adequate dose of folic acid (>5 mg/week total dose or as per local practice) or equivalent and maintained throughout the study.
4) Use of oral corticosteroids of no more than 10 mg prednisone or its equivalent per day is allowed if the dose is stable (defined as no change in prescription) for at least 28 days prior to the first dose of study drug
5) NSAIDs or other analgesics (including aspirin = 100 mg daily) are allowed if doses are stable (defined as no change in prescription) for at least 14 days prior to the first dose of study drug; PRN use for other indications is allowed.
6) No evidence of active or latent TB as demonstrated by a negative QuantiFERON® TB-Gold In-Tube test at Screening. Tests with inconclusive results may be repeated one time. If an inconclusive test is repeated and is returned with inconclusive results a second time, the subject will be excluded from the study. Any prior history of active or latent TB (regardless of treatment) is exclusionary.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1) Prior treatment with B-cell depleting agents (eg, rituximab), unless more than 6 months prior to the first dose of study drug and documented return of CD19+ cells at Screening
2) Prior treatment with any commercially available or investigational SYK inhibitor
3) Concurrent treatment at Screening with any other conventional synthetic DMARD (csDMARD) other than MTX and/or hydroxychloroquine (HCQ) (prior csDMARD treatment allowed if appropriate wash out as defined in Section 5.7)
4) Concurrent treatment at Screening with any bDMARD (prior bDMARD treatment allowed if appropriate wash out as
defined in Section 5.7). Prior failure to treatment with bDMARDs is not an exclusion criterion.
5) QT interval corrected for heart rate using the Fridericia formula (QTcF) > 450 msec determined by the average of values at the Screening visit
6) History of any major bleeding event defined as Grade 3 severity and above (as defined by modified the Common
Terminology Criteria for Adverse Events [CTCAE] 4.03 [Appendix 4]) within the last year or personal or family history of bleeding disorder
OR
Current use of chronic anticoagulant, not including daily aspirin for cardiac prophylaxis
7) Treatment with moderate or strong CYP3A inducers or inhibitors within 2 weeks prior to the first dose of study drug (examples are provided in Section 5.7)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of GS-9876 versus placebo for the treatment of signs and symptoms of RA in subjects with active RA as measured by change from baseline in DAS28 (CRP) at Week 12;Secondary Objective: - To evaluate the safety and tolerability of GS-9876 in subjects with RA<br>- To explore the effect of GS-9876 on other disease-specific outcomes in RA;Primary end point(s): Change from baseline in DAS28 (CRP) at Week 12;Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - The proportion of subjects who achieve ACR 20/50/70 at Week 12<br>- Change from baseline in HAQ-DI score at Week 12;Timepoint(s) of evaluation of this end point: Week 12