A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate
- Conditions
- Rheumatoid ArthritisMedDRA version: 16.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2011-002840-29-CZ
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 280
Principal Inclusion Criteria in Lay Language (for a complete list of inclusion criteria refer to the protocol):
- Be a male or female between 18 and 80 years of age, inclusive.
- Have had a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening.
-Positive test for either anti-cyclic citrullinated peptide (anti-CCP) antibody or rheumatoid factor (RF) in serum at screening.
- Have active RA defined as persistent disease activity with the following criteria: at least 6 swollen and 6 tender joints at the time of screening and at baseline; and serum C-reactive protein >= 0.80 mg/dL at screening.
- Have been treated with, and tolerated methotrexate (MTX) at dosages from 10 to 25 mg/week, inclusive (6 to 16 mg/week, inclusive, for patients in Japan), for a minimum of 6 months prior to screening. Subjects must have a stable MTX dose for a minimum of 8 weeks prior to screening.
- Must be post-menopausal or if pre-menopausal, must use an acceptable form of birth control.
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 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
Principal Exclusion Criteria in Lay Language (for a complete list of exclusion criteria refer to the protocol):
- Have inflammatory diseases other than rheumatoid arthritis, such as Lupus
- Is currently receiving treatment for RA other than methotrexate, NSAIDS, corticosteroids (e.g. prednisone), or pain medicines.
- Have current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled.
- Have received biologic agent for rheumatic disease in the past
- Have a recent (2 months) serious infection
- Have an active infection
- Have had cancer within the past 5 years (except certain skin or cervical conditions)
- Have abused substances or alcohol within the past 2 years
– Have active Hepatitis B or C infection, or infective with HIV.
- Have had active tuberculosis.
- Have had exposure to tuberculosis without preventative treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to assess the efficacy (as measured by the<br>reduction of the signs and symptoms of RA) of JNJ-38518168-ZBQ at doses of 3, 10, and 30 mg/d compared with placebo in subjects with active RA despite concomitant MTX therapy.;Secondary Objective: The secondary objectives are:<br>-To evaluate the safety and tolerability of JNJ-38518168-ZBQ -To characterize the population pharmacokinetics and exposure/response relationship of JNJ-38518168-ZBQ in adults with RA on a stable dose of MTX <br>Exploratory Objectives<br>The exploratory objectives are:<br>-To assess the effect of JNJ-38518168-ZBQ on health-related quality of life (HRQOL)<br>-To assess the effect of JNJ-38518168-ZBQ on various biomarkers;Primary end point(s): The primary endpoint is change from baseline in Disease Activity Score DAS28 (CRP - C-reactive protein) at Week 12;Timepoint(s) of evaluation of this end point: week 12
- Secondary Outcome Measures
Name Time Method