Rheumatoid arthritis
Conditions
Interventions
Product Code: ART621
Pharmaceutical Form: Solution for injection
Current Sponsor code: ART621
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Sponsors
Arana Therapeutics Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: • 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 ;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 | — |
Countries
Czech Republic
Outcome results
None listed