Clinical trial NCT00712114 (phase 1/phase 2, status: completed)
Conditions: rheumatoid arthritis
ICD codes: M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019
Drugs: he3286, he3286, he3286
SMILES: C[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@@]2(O)C#C)[C@@H](O)C=C1C[C@@H](O)CC[C@]31C, C[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@@]2(O)C#C)[C@@H](O)C=C1C[C@@H](O)CC[C@]31C, C[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@@]2(O)C#C)[C@@H](O)C=C1C[C@@H](O)CC[C@]31C
Eligibility criteria:

        Main Inclusion Criteria:

          -  Male or female patient 18-75 years of age

          -  Patient with stable or active disease on a stable dose of methotrexate for at least 30
             days prior to Day 1

          -  Patient has normal thyroid stimulating hormone (TSH) levels with or without thyroid
             replacement therapy

          -  Patient is willing to abstain from consuming grapefruit containing products from 24
             hours prior to dosing until the end of the study as it may affect the pharmacokinetic
             measurements

          -  Patient has not experienced renal or liver disease by history and/or based on
             laboratory results

          -  Patient has not experienced acute cardiac disease within 6 months prior to Screening

          -  Patient must provide voluntary, written, informed consent prior to screening
             evaluations and be able to follow verbal and written instructions.

        Main Exclusion Criteria:

          -  Functional status class IV according to The American College of Rheumatology (ACR)
             criteria

          -  Patient who has a history of clinically significant cardiovascular disease (including
             coronary artery disease), clinically significant hepatic, respiratory or renal
             abnormalities, or clinically significant endocrine disorders (including diabetes)

          -  Patient with active Tuberculosis (TB) or evidence of latent TB without previous
             adequate therapy

          -  Systemic autoimmune disorder (including, but not limited to, systemic lupus
             erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed
             connective tissue disease or any overlap syndrome)

          -  Inflammatory joint disease other than RA

          -  Patient who has received any of the following immunosuppressive drugs:

               -  Etanercept within 1 month of Day 1;

               -  Abatacept, adalimumab, infliximab, leflunomide, imuran, cyclosporin, anakinra,
                  sulfasalazine, bextra, celebrex or gold within 2 months of Day 1 or for
                  biological agents 6 half lives, whichever is greater;

               -  Rituximab within 1 year of Day 1

          -  Patient that is bed or wheelchair bound

          -  Patients taking prednisone within 2 weeks prior to Screening

          -  Patient requiring or receiving any of the following within thirty (30) days prior to
             the screening visit: interleukins, steroids (i.e., anabolic steroids,
             glucocorticoids), hormone replacement therapy (except stable low-dose HRT for at least
             6-months prior to screening), birth control pills, anti-cancer chemotherapeutic agents
             (except methotrexate), metabolic inhibitors (except methotrexate), concomitant
             medications that prolong the QT/QTc interval

          -  Patient who has any clinically significant abnormalities in laboratory results at
             Screening