E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | rheumatoid arthritis |
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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 |
The main purpose of this study is to investigate whether rituximab, a new monoclonal antibody used in the treatment of severe rheumatoid arthritis, protects bone. To this end we will measure markers of bone turnover in blood and measure bone density of the spine, forearms and hips with a so-called DEXA scanner before and one year after the first infusion of rituximab. |
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E.2.2 | Secondary objectives of the trial |
Rituximab is a relatively new drug to treat rheumatoid arthritis and many aspects of its mechanism of action are still unclear. We therefore want to use this opportunity to investigate in more detail how rituximab affects the activity of the immune system. We are particularly interested to learn whether and how rituximab treatment restores the imbalanced immune function by studying reactivity of immune cells (B and T lymphocytes) from blood against autoantigens. We also like to investigate whether the effects of rituximab on bone are associated with effects on the immune system. Cells from the immune system, including B lymphocytes, arise in the bone marrow of long bones, and are known to interact closely with bone cells.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Mimimum age 18 years. 2. Diagnosis of rheumatoid arthritis according to ACR classification criteria. 3. Eligibility for treatment with rituximab according to NICE-guidelines 4. First treatment course of rituximab within 6 weeks after screening 5. Written informed consent
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E.4 | Principal exclusion criteria |
1. Use of bisphosphonates 2. Previous B-cell depleting therapy 3. Poor compliance of the patient as assessed by the referring physicians.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in bone mineral density of spine as measured by DXA |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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) | 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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Information not present in EudraCT |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
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 | No |
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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One year after start of treatment of the last patient enrolled. |
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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 | 2 |
E.8.9.1 | In the Member State concerned days | |
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 | 2 |