A Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis

Phase 3

Completed

Conditions: Active Rheumatoid Arthritis
10003816

Registration Number: NL-OMON45232

Lead Sponsor: Sun Pharma Global FZE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

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 recently switched from a period with -well documented- remission or low disease activity to an active disease (DAS28 * 3.2). This documentation is either based on available detailed DAS28 values (increase in DAS28 > 1.2 or > 0.6 if DAS28 * 3.2 compared to last DAS28 measurement (maximum 06 months before), or on a clear description of the previous low disease state by the treating physician (maximum 06 months before). The increase in disease activity has to be RA related. Willing and able to comply with the study protocol visits, assessments and accessible for follow up.
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
* * To adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide at least 2 months prior to study entry and must continue to use contraception for the duration of the study
* * Subjects who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject) may participate in study.
* * All female subjects of child-bearing potential must have a negative urine pregnancy test
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.

Exclusion Criteria

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 (more than one per person) 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 HIV antibody screen, based on the current medical data of the patient.
6. Abnormal hepatic function (ALT/AST or bilirubin > 2 x upper limit of normal) at the time of the Screening Visit.
7. Abnormal renal function (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 Principal Investigator.
9. Treatment with oral, rectal or injectable (including intra-articular) glucocorticoids (GC) within 6 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
10. Contraindication for glucocorticosteroids
11. Neuropathies or other painful conditions that might interfere with pain evaluation, as judged by the Investigator.