E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ACTIVE RHEUMATOID ARTHRITIS |
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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 |
Evaluate the efficacy of two doses of CRx-139 plus DMARD therapy to steroid plus DMARD therapy using ACR-20 in subjects with active rheumatoid arthritis after 8 weeks of treatment. |
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E.2.2 | Secondary objectives of the trial |
•Evaluate the efficacy of two doses of CRx-139 plus DMARD therapy to steroid plus DMARD therapy using DAS28 in subjects with active rheumatoid arthritis after 8 weeks of treatment. •Evaluate the efficacy of two doses of CRx-139 plus DMARD therapy to steroid plus DMARD therapy in lowering CRP levels in subjects with active rheumatoid arthritis after 8 weeks of treatment. •Evaluate the changes in inflammatory cytokines in subjects treated with two doses of CRx-139 plus DMARD therapy to steroid plus DMARD therapy in subjects with active rheumatoid arthritis after 8 weeks of treatment. •Compare the changes in the same variables at the end of the Combination Treatment Period and at the end of the Withdrawal Period, for groups withdrawn to DMARD therapy plus steroid, 10 mg paroxetine, 20 mg paroxetine, or placebo.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
•Subject must be at least 18 years of age. •Subject must have active, moderate to severe rheumatoid arthritis. •Subject must have at least 6 swollen joints (max = 66) and 9 tender joints (max = 68). •Subject must have been on DMARD(s) for at least 3 months and be on a stable dose of DMARD(s) for at least 1 month (2 months for methotrexate) prior to Baseline. Subjects on stable methotrexate may receive it by the parenteral or oral route, but the route must remain constant throughout the study. •Subject must have voluntarily signed the informed consent.
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E.4 | Principal exclusion criteria |
• Subject has any serious medical condition likely to interfere with the objectives of the study (namely evaluation of changes in ACR-20 brought about by CRx-139). This may include the need to take interfering medications or undergo alternative treatments. Patients with peptic ulcers, active tuberculosis, or acute psychosis are specifically excluded, as are patients taking Thioridazin and patients who have taken any MAO-inhibitor within 2 weeks before entering this study. • Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (barriers or abstinence). Subjects on a stable dose (minimum of 6 months) of hormonal birth control may participate in the study. • Subject is currently taking any steroids (glucocorticoids). All glucocorticoids must be discontinued for at least one month (≥ 28 days) prior to Baseline. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given for 6 weeks prior to Baseline. An inhaled glucocorticoid is permitted. • Subject has been treated with the anti-TNFα biologics Remicade® or Humira®, or any other prescription biological drug, within 2 months prior to Baseline, or Enbrel® within 1 month prior to Baseline. • Subject is currently taking any anti-depressants or anti-seizure medications. • Subject has a history of depression, bipolar disorder or schizophrenia; or, in the investigator’s opinion, has any sign of clinical depression, bipolar disorder or schizophrenia. • Subject has a history of seizure disorders. • 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 Baseline. • Subject has any active infections or has had any surgical procedures within 30 days of Baseline. • Subject has severe osteoporosis as determined by the physician, or defined by a fracture within 6 months of Baseline. • Subject has poorly controlled diabetes mellitus as defined by an HbA1C value ≥ 7.0%. •Subject is known to have HIV or Hepatitis. •Subject is currently participating in a clinical research study, or has undergone administration of any investigational drug within 30 days of Baseline. •Subject has a history of hypersensitivity to steroids and/or selective serotonin re-uptake inhibitors. •Subject is not ambulatory. •Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluate the difference in ACR-20 response between rheumatoid arthritis subjects treated with each of two doses of CRx-139 plus DMARD therapy and subjects treated with steroid plus DMARD therapy after 8 weeks of treatment. |
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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) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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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 | |