A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid Arthritis
- Conditions
- Active Rheumatoid ArthritisTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-002924-17-NL
- Lead Sponsor
- Sun Pharma Global FZE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
1)Male or female = 18 years old.
2)Known Diagnosed RA according to the revised 2010 ACR/EULAR Rheumatoid Arthritis Classification Criteria. Secondary Sjögren’s syndrome with RA is permitted.
3)Male and female subjects with active RA who are experiencing a flare / exacerbation defined as a recent increase in symptoms and a measured increase in DAS28 > 1.2 or > 0.6 if DAS28 = 3.2 compared to last DAS28 measurement (maximum 6 months before). The increase in DAS28 has to be RA related.
4)Willing and able to comply with the study protocol visits, assessments and accessible for follow up.
5)Subjects naïve to treatment and/or currently not treated for at least 8 Weeks prior to the Screening Visit and willing to continue without non-study treatment for 12 Weeks, or subjects on stable treatment with DMARD (including biologicals) for at least 8 Weeks prior to the Screening Visit and willing to continue current stable treatment for 12 Weeks.
6)Subjects able and willing to give written informed consent (or legally acceptable representative or impartial witness when applicable) and is available for entire study.
7)Subjects of child bearing potential should be non-lactating and must be practicing an acceptable method of birth control as judged by the Investigator. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (e.g., Depo Provera™), an intrauterine device, vasectomized partner, an oral contraceptive taken continually within the past three months and which the subject agrees to continue using during the study.
8)Male subjects enrolled in the study are advised to prevent passage of semen to their sexual partner during intercourse using acceptable methods as judged by the investigator.
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1)Rheumatic autoimmune disease other than RA, e.g., systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis.
2)Current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, spondyloarthritis, Lyme disease, osteoarthritis).
3)Subjects who are pregnant or intend to become pregnant during the study.
4)Have a family history (more than one first degree relative) of multiple thrombotic events or a personal history of any venous or arterial thrombotic event including deep vein thrombosis, stroke, myocardial infarction, pulmonary embolus, and peripheral arterial thromboembolic events or abnormal ECG which may impact the subject’s safety as per Investigator’s opinion.
5)Subject with positive hepatitis panel (including hepatitis B surface antigen [HBsAg], and / or anti-hepatitis B core antibodies, and / or hepatitis C virus antibody [anti-HCV]), and / or a positive Human immunodeficiency virus (HIV) antibody screen, based on the current medical data of the patient.
6)Abnormal hepatic function [alanine aminotransferase (ALT)/aspartate aminotransferase (AST) or bilirubin > 2 x upper limit of normal] at the time of the Screening Visit.
7)Abnormal renal function [Blood Urea Nitrogen (BUN) or creatinine >1.25 x upper limit of normal] at the time of the Screening Visit.
8)Clinically significant out-of-range values on hematology panel, at discretion of the PI.
9)Treatment with oral, rectal or injectable (including intra-articular) glucocorticoids (GCs) within 8 Weeks prior to Screening Visit. Inhaled glucocorticoids are allowed. Topical steroids are allowed, however subjects should not have received more than 100 gram of a mild to moderate topical corticosteroid cream per Week, 50 gram of a potent corticosteroid cream per Week or 30 gram of a very potent topical corticosteroid cream per Week in the 4 Weeks prior to the Screening Visit.
10) Subjects who have received an investigational drug within 30 Days prior to the Screening visit.
11) Previous treatment with IV gamma globulin, plasmapheresis or Prosorba® column within 3 months prior to Screening.
12) Known sensitivity to any component of the study drug or previous hypersensitivity reaction or other clinically significant reaction to IV medications, biologic therapy or IV radiocontrast agents.
13)Contraindication for glucocorticoids as judged by Investigator.
14) Subjects who have previously received Nanocort.
15) Neuropathies or other painful conditions that might interfere with pain evaluation, as judged by the Investigator.
16) Active infection requiring systemic treatment.
17) Planned surgery during the study period or had undergone major surgery within the 60 Days prior to the Screening visit.
18) Requirement for immunizations or vaccinations during the study period.
19) Subjects with poor peripheral venous access as per Investigator or site personnel opinion.
20)History of substance abuse or alcohol abuse.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess efficacy and safety (treatment of signs and symptoms) of Nanocort in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation in comparison to a standard of care medication (Depo-Medrol). ;Timepoint(s) of evaluation of this end point: Week 1 (Day 8);Secondary Objective: Patient Reported Outcomes and an assessment of pharmacokinetic parameters in a subset population from each treatment group. ;<br> Primary end point(s): Primary Endpoint: European League Against Rheumatism (EULAR) responder (moderate and good combined) rate at Week 1 (Day 8)<br>
- Secondary Outcome Measures
Name Time Method