CLINICAL TRIALS
WINELANDS MEDICAL RESEARCH CENTRE
Founded in 2010, we are one of the largest and most productive rheumatology clinical trial centres in Southern Africa.
WMRC is affiliated with the Divisions of Rheumatology at IOR, Winelands Rheumatology Centre as well as Stellenbosch University and the University of Cape Town.
CLINICAL TRIALS
WINELANDS MEDICAL RESEARCH CENTRE
All of our rheumatologists are actively involved in clinical research and teaching.
ABOUT
WMRC is committed to conducting clinical research in a highly professional, responsible and ethical way.
The centre has undergone successful audits by SAHPRA, and a number of local and international pharmaceutical and clinical research organisations.
CLINICAL TRIALS
- Receiving regular consultations for your condition with a Rheumatologist or Family Physician.
- Consultations, as well as protocol required tests, i.e. ECGs, Xrays and blood tests are covered by the sponsor and do not cost the patient anything.
- A travel fee is paid to the participant to cover the costs of attending the required visits to site.
- Access to medication that are not available, due to medical aid restrictions, no medical aid membership and medication not yet approved in RSA but available in other countries in the world.
Whatever the motivation, when you choose to participate in a clinical trial, you become a partner in scientific discovery. Without the generosity of clinical trial participants, major medical breakthroughs could not be possible.
RECRUITMENT
Clinic trials currently open for recruitment
Systemic Lupus Erythematosus
A phase 3 programme to evaluate the safety and efficacy of Upadacitinib in subjects with moderately to severely active systemic lupus erythematosus. (Select-SLE)
Protocol
- Male or female participants 18 to 63 years of age
- Clinical diagnosis of SLE for at least 24 weeks
- Active SLE with a positive ANA or anti-dsDNA or anti Smith
- Stable background treatment for SLE should have been initiated for at least 30 days
- No prior use of JAK inhibitors permitted
- No planned, elective surgery permitted for duration of the study
- Pregnancy and breastfeeding not permitted
- Class III/IV lupus nephritis not permitted
- Uncontrolled hypertension defined as persistent systolic BP >160 mmHg or diastolic BP > 100mmHg is not permitted
- 2 year study, with open-label Upadacitinib 15mg or 30 mg administered in 2nd year
- There is a possibility of receiving Upadacitinib for up to 4 years after study participation
- Visits to the site are monthly for the 1st year, thereafter they are less frequent
Rheumatoid Arthritis
A phase 3b/4 randomised, double-blind. Double-dummy, active comparator-controlled study, comparing the efficacy and safety of Upadacitinib versus Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis on a stable background of MTX and who had an inadequate response or intolerance to a single TNF Inhibitor (SELECT-SWITCH)
Protocol
- Participants must be 18 years of age or older
- A diagnosis of Rheumatoid Arthritis should have been made for at least 3 months duration
- Treatment with 1 TNFi ( except Adalimumab) for at least 3 consecutive months
- Current treatment must include Methotrexate at a dose of between 15 – 25 mg weekly
- No previous exposure to any JAK inhibitor
- Arthritis onset before the age of 17 years is not permitted
- Pregnancy or breastfeeding not permitted
- 1 year study with site visits at Weeks 2, 6, 12, 24, 36 and 48
Systemic Lupus Erythematosus
A randomised, double-blind, parallel group, placebo controlled multicentre phase 3 study to evaluate efficacy, safety and tolerability of t regimens of ianalumab on top of standard of care therapy in patients with systemic lupus erythematosus. ( SIRIUS-SLE 1)
Protocol
- Male or female persons aged 12 years or older
- Confirmed diagnosis of SLE for at least 6 months
- Elevated ANA serum titre at screening is required
- Active SLE inspite of background therapy
- Treatment with corticosteroids and/or antimalarials and/or DMARDs is required
- Prior use of B-cell therapies will require a washout period
- Any uncontrolled, co-existing serious disease is not permitted
- Evidence of malignancy in the last 5 years not permitted
- Pregnancy or breastfeeding not permitted
DOCTORS
Our Rheumatology Specialists
Prof. Helmuth Reuter
RHEUMATOLOGIST
Research Lead and Liason, Rheumatology
Dr. Gareth Tarr
SPECIALIST PHYSICIAN / RHEUMATOLOGIST
Rheumatology
