E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | Compare the response of CRx-150 plus DMARD therapy to placebo plus DMARD therapy in lowering CRP levels in rheumatoid arthritis subjects. | |
E.2.2 | Secondary objectives of the trial | Evaluate the changes in inflammatory cytokines in subjects treated with CRx-150 plus DMARD therapy to placebo plus DMARD therapy. Evaluate the efficacy of CRx-150 plus DMARD therapy to placebo plus DMARD therapy using ACR-20 and DAS28 indices | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria | 1.Subject must be at least 18 years of ages. 2.Have rheumatoid arthritis. 3.Have at least 5 swollen joints (max = 66) and 6 tender joints (max = 68). 4.Subject must have baseline C-reactive protein levels of at least 3.0 mg/L. 5.Subject must have been on DMARD therapy for at least 3 months and be on a stable dose of DMARD therapy for at least 28 days prior to enrollment. Subjects on stable methotrexate may receive it by the parenteral or oral route. 6.Subject must have voluntarily signed the informed consent. | |
E.4 | Principal exclusion criteria | 1.Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (barriers or abstinence). Female subjects using hormonal birth control are not to be enrolled. 2.Subject is currently taking any steroids (glucocorticoids). All glucocorticoids must be discontinued for at least one month prior to entering study. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study. 3.Subject is currently taking any anti-depressant or anti-seizure medications. 4.Subject has a history of seizure disorders. 5.Subject had a myocardial infarction within six months of enrollment. 6.Subject is currently taking more than 81 mg of aspirin daily. 7.Subject has a history of asthma, which is being treated with inhaled or other steroids. 8.Subject is currently taking a statin, unless she/he has been on a stable dose of the same statin for at least 3 months prior to entering into the trial. 9.Subject has any active infections or recent surgical procedures within 30 days of study initiation. 10.Subject has uncontrolled diabetes mellitus as defined by a HbA1C value ≥ 7.0%. 11.Subject knowingly has HIV or Hepatitis. 12.Subject is currently participating in a clinical research study, or has undergone administration of any investigational drug within 30 days of study initiation. 13.Subject has a history of hypersensitivity to tri-cyclic anti-depressants and/or dipyridamole. 14.Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided. | |
E.5 End points |
E.5.1 | Primary end point(s) | Compare the reduction in CRP levels between subjects treated with CRx-150 plus DMARD therapy and subjects treated with placebo plus DMARD therapy. | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 | The trial involves single site in the Member State concerned | Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |