A multi-centre, double blind, randomised, placebo-controlled, parallel group, phase II trial to determine the efficacy of intra-nodular injection of anti-TNF to control disease progression in early Dupuytren*s Disease
- Conditions
- Dupuytren's Disease1001076110040790
- Registration Number
- NL-OMON47684
- Lead Sponsor
- niversity of Oxford, Research Services, Clinical Trials and Research Governance, Joint Research Office, Boundary Brook House
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Participants with early disease nodules who have shown or reported progression of the disease in the previous 6 months with flexion deformities of their fingers of *30° at the metacarpophalangeal and/or at the proximal interphalangeal joint, i.e. total flexion deformity of up to 60°.
* The DD nodule to be treated must be distinct and identifiable.
* Female participants of child bearing potential, and male participants whose partner is of child bearing potential, must be willing to ensure that they or their partner use effective contraception throughout the treatment period and for 5 months following the last research injection.
* Participant results from safety screening tests within normal ranges within 12 weeks of enrolment.
* Able (in the Investigators opinion) and willing to comply with all study requirements.
* Willing to allow his or her general practitioner to be notified of participation in the study.
* Sufficient language fluency to ensure informed consent is obtained and to complete the questionnaires pertaining to hand function.
* Participant has previously had fasciectomy, dermofasciectomy, needle fasciotomy, collagenase injection, steroid injection to the digit to be treated or radiotherapy to to treat Dupuytren's disease in the hand concerned.
* Female participant who is pregnant, lactating or planning pregnancy during the course of the study and for 5 months following last injection.
* Male participant who is planning a pregnancy during the course of the study and for 5 months following last injection.
* Significant renal or hepatic impairment.
* Participant who has ever been diagnosed with cancer, is terminally ill or is inappropriate for placebo medication.
* Systemic inflammatory disorder such as RA or inflammatory bowel disease.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants 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.
* Participated in another research study involving an investigational medicinal product in the past 12 weeks.
* Known allergy to any anti-TNF agent.
* Have HIV or hepatitis B or C.
* Known to have an infection or history of repeated infections.
* History of Tuberculosis (TB).
* Have Multiple Sclerosis (MS) or other demyelinating disease.
* History of local injection site reactions.
* Needle phobia.
* Have moderate or severe heart failure.
* Have known lung fibrosis (thickening of lung tissue).
* Being treated with concomitant biologic DMARDS.
* Have received a live vaccine within the previous 4 weeks. Participants may receive concurrent vaccinations but must avoid the use of live vaccines for 12 weeks after their last injection.
* Patients at risk of Hepatitis B infection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in hardness of selected nodule for participants on each treatment<br /><br>baseline and 12 months after first treatment..</p><br>
- Secondary Outcome Measures
Name Time Method <p>For participants on each treatment.<br /><br>1.Change in hardness of selected nodule for participants on each treatment at<br /><br>baseline, 3, 6, 9, 12 & 18 months after first treatment.<br /><br>2. Ultrasound imaging of nodule size.<br /><br>3. Range of motion of the affected digit.<br /><br>4. Grip strength.<br /><br>5. Participant Reported Outcomes:<br /><br>Michigan Hand Outcomes Questionnaire (MHQ)<br /><br>6. Participant identified activity most restricted by DD scored on a scale of<br /><br>1-10.<br /><br>7. Progression to surgery of the digit being assessed<br /><br>8. Injection experience<br /><br>9. Adverse event monitoring comparing active and placebo groups using visual<br /><br>inspection of injection site.</p><br>