E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Dupuytren’s Contracture is a common problem of the hand caused by fibrous tissue build up, which forces the finger to bend down into the palm leading to an inability to straighten the finger. |
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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 | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10013872 |
E.1.2 | Term | Dupuytren's contracture |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10013873 |
E.1.2 | Term | Dupuytren's contracture operation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
To investigate whether collagenase injection is as good as surgery (limited fasciectomy) in the correction of Dupuytren’s contracture of the hand |
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E.2.2 | Secondary objectives of the trial |
To investigate the cost-effectiveness of collagenase injections compared to surgery (limited fasciectomy) 2 years after treatment.
To investigate whether the correction achieved after collagenase injection or surgery is maintained to 5 years (If justified by findings from the analysis at 1 year and 2 years)
To explore patient’s experiences and preferences of the different treatments (Qualitative sub study).
To investigate if remote measurement (using photographs) of finger extension is as good as goniometric measurements in clinic to determine recurrence (Photography sub study).
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
1. Qualitative sub-study: If a patient agrees to take part in the qualitative sub-study they may be asked to participate in a semi-structured interview to generate information on benefits and difficulties associated with each treatment.
2. Photography sub-study: If a patient agrees to take part in the photography sub-study, they will be asked to take photographs of their hand at baseline, 3 months and 6 months and to send these to the study team. Patients will be provided with instructions on how to complete the photographs |
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E.3 | Principal inclusion criteria |
• Male or Female and aged 18 years or over • Presence of discrete, palpable, contracted cord involving the metacarpophalangeal joint and/or proximal interphalangeal joint of a finger • Degree of contracture >30 degrees in either joint i.e. patient cannot put the palm of the hand flat on a table (Hueston’s Tabletop test) • Able to identify a predominant finger for treatment which would not require more than one collagenase injection as treatment for a single cord • Appropriate for limited fasciectomy and collagenase injection for Dupuytren’s contracture (i.e. not requiring skin grafting or PNF (eg discrete MCP cords in elderly)) • Patient is willing and able to give informed consent for participation in the study.
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E.4 | Principal exclusion criteria |
• Severe contractures of both metacarpophalangeal joint and/or proximal interphalangeal joints (Tubiana Grade 4) • History of previous intervention for Dupuytren’s contracture (e.g. limited fasciectomy, collagenase injection or needle fasciectomy) on the same hand • History of any other pre-existing disorder of the hand causing restriction of movement and/or pain and affecting hand function e.g. post traumatic stiffness, stiffness due to other causes, infection, arthritis • Non-English speaking because of the need to complete multiple questionnaires which have not been validated in multiple languages • Resident in a location where attendance for follow up at one of the study recruiting centres will not be possible • Contraindicated for use of Collagenase • Any other significant disease or disorder (including autoimmune disorders) which, in the opinion of the Investigator, may put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. • Participants who have participated in another research study involving an investigational product in the past 12 weeks • Female participants who are pregnant or breastfeeding
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is change in Patient Evaluation Measure (PEM) between baseline and 1 year. PEM is a validated patient report questionnaire of 11 items in the Hand Health and three in the Overall Assessment Questionnaire (including a transition question). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, 3 months, 6 months, 1 year and 2 years after the intervention is delivered |
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E.5.2 | Secondary end point(s) |
- Unité Patient Rated Outcome Measure (URAM): A validated, nine item, six interval disease specific disability scale. - Michigan Hand Questionnaire (MHQ): A validated, 63 question measure featuring six domains relating to hand function, daily living, pain and aesthetics. - EQ-5D-5L: A validated, generic health status measure accompanied by a health status thermometer visual analogue scale (VAS). - Resource Use: Patient reported - Further Procedures: Clinician and Patient reported - Complications: Clinician and Patient reported - Recurrence: Assessed by clinicians during follow up visits, using the primary definition - change in extension deficit of 6 degrees between 3 and 6 months, or 20 degrees from 3 months to 1 year post treatment. - Extension deficit and total active movement: Assessed by clinicians during follow up visits. - Time to recovery of function: The SANE question, "From 0 – 100%, where do you put yourself currently in regards to your prior level of function?" collected from participants using postcards. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, 3 months, 6 months, 1 year and 2 years after the intervention is delivered, with the exception of the SANE question which is also collected at 2 and 6 weeks. The Michigan Hand Question will only be collected on an annual basis after Baseline. |
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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 | 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 | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Surgery (limited fasciectomy) |
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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
| 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 | 22 |
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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End of this trial will be last visit 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 | 4 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 31 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 31 |