Intervention: Prednisolone
Trial phase: Phase 2
ATC code: A01AC04 | A01AC54 | A07EA01 | C05AA04 | D07AA03 | D07BA01 | D07CA03 | D07XA02 | H02AB06 | R01AD02 | R01AD52 | S01BA04 | S01BB02 | S01CA02 | S01CB02 | S02BA03 | S02CA01 | S03BA02 | S03CA02 | V03AB05
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: prednisolone

prednisolone: prednisolone (2.7 mg)
Eligibility criteria:
Inclusion Criteria:

Subject must voluntarily give written informed consent
Subject must be ≥ 18 years of age
Subject must have RA (ACR criteria)
Subject must have at least 4 swollen joints and at least 6 tender joints at screening and baseline (28 joint count)
Subject must have a CRP > Upper Limit of Normal at screening
Subject must have been on DMARD or DMARD combination (e.g. MTX + hydroxychloroquine) for at least 3 months and be on a stable dose of DMARD(s) for at least 6 weeks prior to screening.
For MTX subjects: MTX ≥ 7.5 mg weekly (po/sc/im) and willing to take folic acid or folinic acid supplementation
Subject willing to take concomitant multivitamin or the equivalent of 400 I.U. vitamin D and the equivalent of 1000 mg of elemental calcium daily

Exclusion Criteria:

History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease
Wheelchair or bed bound
History of osteoporotic fracture
History of malignancy within the past 10 years. However, subjects with a history of treated or excised basal cell carcinoma or fewer than 3 squamous cell carcinomas are eligible to participate
History of lymphoma or chronic leukemia
Moles or lesions that are currently undiagnosed, but are suspicious for malignancy
Surgery within the previous 3 months (except for minor dental and cosmetic)
History of drug or alcohol abuse (as defined by the Investigator)
History of bleeding disorder
History of gastrointestinal bleeding within 5 years of screening
History of severe migraines or headaches
History of glaucoma
Active diabetic retinopathy
Visually compromising cataract
History of opportunistic infection within the previous 12 months
Active Tuberculosis (TB)
Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening
Fever or symptomatic viral or bacterial infection within 2 weeks prior to screening
Positive for Hepatitis C virus (HCV) antibody
Positive for HBsAg
Known positive HIV antibody
Has a history of hypersensitivity to glucocorticoids and/or dipyridamole
Treatment with oral, intra-articular, intramuscular, or intravenous glucocorticoids within 6 weeks prior to screening; inhaled glucocorticoid is permitted
Treatment with any tumor necrosis factor-alpha (TNFα) biologic, anakinra or abatacept within 2 months prior to screening
Treatment with rituximab
Treatment with another investigational drug 3 months prior to screening
Treatment with anticoagulants including: dipyridamole, warfarin, clopidogrel, ticlopidine; Acetylsalicylic acid > 150 mg per day
Treatment with any concomitant medications that have not been at a stable dose for at least 28 days prior to screening
Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) laboratory values that exceed 1.5 x ULN
HbA1C value of > 7.0%
Current enrollment in any other study with investigational drug or device
Female subject who is pregnant or lactating or of child bearing potential and not using acceptable methods of contraception (birth control pills, barriers or abstinence)
Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule
Other unspecified reasons that, in the opinion of the Investigator or sponsor make the subject unsuitable for enrollment