E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language |
Treatment of Tenosynovitis |
Behandling af seneskedehindebetændelse |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042869 |
E.1.2 | Term | Synovitis and tenosynovitis |
E.1.2 | System Organ Class | 100000004859 |
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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 |
Explore whether ultrasound-guided glucocorticoid injection in the synovial sheath has better effect than intramuscularly glucocorticoid injection among patients with tenosynovitis, assessed by US examination, pain VAS-score and clinical evaluation. |
Belyse om ultralyd-guided glucocorticoid injektion i seneskeden har bedre effekt end intramuskulær glucocorticoid injektion hos patienter med tenosynovit, vurderet ved hjælp af ultralyd-undersøgelse, smerte VAS-score og klinisk vurdering. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Ultrasonic signs of treatment demanding tenosynovitis in flexor or extensor tendons in the hand (1st - 6th compatment) or flexor- , extensor-, or peroneus tendons in the ankle.
Rheumatoid arthritis according to ACR/EULAR 2010 criteria
Above 18 years of age
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Ultrasonisk tegn på behandlingskrævende tenosynovit i håndens flexor- eller ekstensorsener (1. – 6. kulisse) eller ankelens flexor-, ekstensor-, eller peroneussener.
Reumatoid artrit I henhold til ACR/EULAR 2010 kriterier.
Alder over 18 år.
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E.4 | Principal exclusion criteria |
Lack of ability to understand the information given about the study.
Recent operation in hands or feet.
Start of Disease-modifying anti-rheumatic drugs (DMARDs) / biological treatment within the last 12 weeks
Change of DMARD / biological or glucocorticoid treatment within the last 6 weeks.
Allergy to betamethasone.
Start of Non-Steroidal Anti-Inflammatory Drugs (NSAID) treatment within the last 10 days.
Systemic fungal infection
Positive urine HCG among women in the age of fertility.
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Manglende evne til at forstå informationen om studiet.
Nylig operation i hænder eller fødder.
Opstart af Disease-modifying anti-rheumatic drugs (DMARD)/biologisk behandling indenfor de sidste 12 uger
Ændring af DMARD/biologisk eller glucocorticoid behandlingen indenfor de seneste 6 uger.
Allergi for betamethason.
Opstart af Non-Steroidal Anti-Inflammatory Drugs (NSAID) behandling indenfor de sidste 10 dage.
Systemisk svampeinfektion
Positiv Urin HCG hos kvinder i den fertile alder. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Differences in the scoring of tenosynovitis evaluated by US, between treatment arm A and B (US-tenosynovitis scoring ≤ 1 4 weeks after the injektion), assessed by the Mann-Whitney U test. |
Forskelle i tenosynovit scoring, bestemt ved UL, mellem behandlings arm A og B (UL-tenosynovit scoring ≤ 1 ved tiden 4 uger efter injektion), bedømt ved Mann-Whitney U test.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After the last visit of the last subject. |
Efter sidste besøg, af sidste deltager. |
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E.5.2 | Secondary end point(s) |
Changes in the patient parameters (Clinical and US-sound assessment, as well as the participant’s own reporting and visual Analog Scale for tenosynovitis) assessed by Wilcoxon Pratt test after 2, 4 and 12 weeks.
Correlation between findings (Clinical and US-sound assessment, as well as the participant’s own reporting and visual Analog Scale for tenosynovitis) , assessed by Spearman's correlation analysis after 2, 4 and 12 weeks.
Differences in the scoring of tenosynovitis evaluated by US, between treatment arm A and B (US-tenosynovitis scoring ≤ 1 12 weeks after the injektion), assessed by the Mann-Whitney U test.
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Ændringer i patient parametre (klinisk og UL-mæssig vurdering samt deltagers egen rapportering og visuel Analog Skala for tenosynovitis), vurderet ved WilcoxonPratt test efter 2, 4 og 12 uger.
Korrelation mellem fund (klinisk og UL-mæssig vurdering samt deltagers egen rapportering og visuel Analog Skala for tenosynovitis) vurderet ved Spearman’s korrelationsanalyse efter 2, 4 og 12 uger.
Forskelle i scoring af tenosynovit bestemt ved UL, mellem behandlings arm A og B (UL-tenosynovit scoring ≤ 1 ved tiden 12 uger efter injektion), bedømt ved Mann-Whitney U test.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After the last visit of the last subject |
Efter sidste besøg, af sidste deltager. |
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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 | 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) | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
CS inj. in the synovial sheath and NaCL Solvens IM vs CS IM and NaCL Solvens inj.in synovial sheath |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |