E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoarthritis of the hand |
artrose van de hand |
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E.1.1.1 | Medical condition in easily understood language |
Osteoathritis of the hand also called arthroses, is an inflammatory conditions of the cartilage joints. |
artrose van de hand |
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E.1.1.2 | Therapeutic area | Body processes [G] - Bones and nerves physological processes [G11] |
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 |
This proof of concept study is to estimate the effect of SRCaBu (600 mg daily for four weeks) on compositional and functional characteristics of the microbiome for future sample size calculation |
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E.2.2 | Secondary objectives of the trial |
1) To evaluate the short-term effects (i.e. 4 5 weeks) of SRCaBu (600 mg dd) compared with placebo on pain and functioning of the hands in hand OA patients. 2) To evaluate whether SRCaBu (600 mg dd) lowers systemic inflammation in hand OA. 3) To evaluate whether immune tolerance will improve while lowering inflammation by characterizing the phenotype of T-cells and monocytes and determining the response of activated PBMCs of patients before and after intake of 600 mg dd SRCaBu. 4) To examine the safety profile of (600 mg dd) SRCaBu in patients with hand OA over 4- 5 weeks. 5) To examine the association between intestine functioning and pain and functioning of the hands in hand OA patients.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age ≥ 50 year and ≤ 75 years, - Osteoarthritis of the hand according to the 1990 ACR diagnostic criteria for hand OA (Altman 1990) in both hands operationalized as: • Hand pain, aching, or stifness and 3 or 4 of the following: • Hard tissue enlargement of 2 or more of 10 selected joints • Hard tissue enlargement of 2 or more DIP joints • Fewer than 3 swollen MCP joints • Deformity of at least 1 of 10 selected joints.
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E.4 | Principal exclusion criteria |
- Recent use of antibiotics (last three months) - Previous surgery of one of the hands - Recent cerebro- or cardiovascular incident (past 6 months) - Diabetes - Other chronic inflammatory disease - Other musculoskeletal diseases than OA with possible hand localisation - Cognitive deficits affecting the scoring process - Received intramuscular of intra-articular corticosteroid injections in the previous 4 weeks - Fibromyalgia according to the 2010 ACR diagnostic criteria for fibromyalgia (Wolfe 2011) - Any other syndrome(s) or condition(s) that could interfere with the assessment of pain - Severe current psychiatric disorders assessed by physician - Self-reported consumption of alcoholic drinks, > 2 units per day
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E.5 End points |
E.5.1 | Primary end point(s) |
A positive treatment effect with respect to microbiome composition and function is an increase in alpha diversity and fraction of strict anaerobes. More specifically, this entails increase in relative abundance of members of the Lachnospiraceae and Ruminococcaceae, including populations of butyrate producers such as Faecalibacterium prausnitzii, and an increase in the abundance of functional genes encoding enzymes involved in butyrate production. Furthermore, a positive treatment effect is a decrease in the abundance of Enterobacteriaceae and genus Streptococcus, and a decrease in genes involved in virulence, LPS production and gut barrier toxin production. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
before start of treartment and ater 4 - 5 treatment weeks |
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E.5.2 | Secondary end point(s) |
barrier function intestine, variables related to systemic inflammation; Variables related to systemic inflammation are: hsCRP, il-1β, il-6, sTNFR1 en sTNFR2, TNFɑ, leptin, uric acid and NOx,; Variables related to immune tolerance and inflammatory responses are: Treg/Th17 balance, activated Th17 and Th1, M1/M2 balance. pain and functioning of hand joints, patiente global assessment, quality of life, defecation
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
All variablble before start of treatment, all variables afte 4-5 treatment weeks Pain, joint function, quality of life, defecation daily |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | 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 | No |
E.8.1.4 | Double blind | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |