E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
To evaluate the long term safety and tolerability of ART621 on the signs and symptoms of moderate to severe RA in patients concomitantly taking methotrexate as assessed by vital signs, clinical chemistry, haematology, urinalysis, physical examination and adverse event reporting |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the long term efficacy of ART621 on the signs and symptoms of moderate to severe RA in patients concomitantly taking methotrexate as assessed by: o the proportion of subjects achieving ACR20, ACR50 and ACR70 responses, o the changes in the ACR hybrid score o changes in individual ACR components o the Disease Activity Score 28 (DAS28) response rate and changes in DAS28 scores o Low Disease Activity Score (LDAS) analysis o erythrocyte sedimentation rate (ESR) o C-reactive protein (CRP) o individual dimensions of the Health Assessment Questionnaire (HAQ) and o the subjects assessment of fatigue • To assess the impact of ART621 on quality of life as assessed by SF-36 and RAQoL questionnaires • To investigate the trough pharmacokinetics of ART621 in subjects with RA. • To assess the effects of ART621 on immunological parameters
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Prior participation in an ART621 clinical trial for rheumatoid arthritis 2. Concomitant doses of methotrexate between 10-25mg/week, oral steroid ≤ 10mg prednisone equivalent/day (if needed) and stable use of up to one concomitant NSAID (if needed) 3. Provision of a valid written informed consent. 4. Demonstrated tolerance of prior ART621 trial medications and procedures. 5. Demonstrated compliance with prior ART621 trial protocol requirements. 6. Is willing and able to comply with current study visits and other protocol requirements.
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E.4 | Principal exclusion criteria |
1. Pregnant, nursing or planning a pregnancy (both men and women) within the next 15 months. 2. Laboratory tests at Screen: o hemoglobin ≤ 8.0 gm/dl o white blood cells ≤ 3.0 x103 cells/µl o neutrophils ≤ 1.5 x 103 cells/µl o platelets ≤ 100 x 103 cells/µl o serum transaminase level (AST and ALT) ≥ 2 times upper limit of normal (ULN) o serum creatinine ≥ 0.15 mmol/l 3. Subjects diagnosed with inflammatory or autoimmune diseases that might confound the evaluations of benefit from ART621 such as ankylosing spondylitis, systemic lupus erythematosus and Lyme disease. 4. Subjects who may require plasmapheresis during the 48 week study period. 5. Subjects who have developed clinically significant adverse reaction to murine or chimeric proteins, including serious allergic reactions during or since participation in the previous ART621 study. 6. Subjects who are expected to receive any live virus or bacterial vaccinations during the 48 week study period. 7. Subjects with presence of, or at high risk of serious infection including: o tuberculosis o a serious infection during the past 3 months (hospitalised or received IV antibiotics for an infection) o chronic or recurrent infectious disease. o systemic fungal infections o opportunistic infection within the past 3 months (refer to 1993 CDC Classification System for HIV Infection) o HIV, hepatitis B, or hepatitis C o subjects with planned joint replacement surgery or a history of infected joint prosthesis or who have received antibiotics for a suspected infection of a joint prosthesis if that prosthesis has not been removed or replaced during the past 3 months 8. Subjects with contraindications to anti-TNF therapy including demyelinating diseases, congestive heart failure, evidence of malignancy, lymphoproliferative or neoplastic disease. 9. Subjects who have, or are at risk of developing, severe, progressive or uncontrolled concomitant medical conditions. 10. Subjects who have received cytotoxic drugs including cyclophosphamide, cyclosporine, or alkylating agents since commencement of the previous ART621 study or who will require such therapies during the current study. 11. Participation in any other investigational study during the 48 week study period. 12. Any other clinically significant disease or disorder or factors such as substance abuse which in the opinion of the investigator make the subject ineligible for participation in this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
LONG TERM SAFETY AND TOLERABILTIY OF ART621 ON THE SIGNS AND SYMPTOMS OF RA AS ASSSESSED BY: - VITAL SIGNS - CLINICAL CHEMISTRY - HAEMATOLOGY - URINALYSIS - PHYSICAL EXAMINATION AND ADVERSE EVENT REPORTING
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
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 | Yes |
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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Last visit of last subject |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |