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
Osteoarthritis [209978]
A multicentre randomised, double-blind, placebo controlled, dose-finding, Phase 2 study of GSK3858279 in adult participants with moderate to severe knee pain.
Protocol 209978:
- Participants should be between the ages of 40 to 80 years of age
- History of inadequate response, intolerance or contraindication to at least 1 pharmacological therapy for knee OA pain
- Average daily pain score between 4 & 9 out of 10 in the index knee
- No history of significant trauma or surgery to a knee or hip within the last 6 months
- No history of malignancies in the last 5 years except resected basal cell or squamous epithelial carcinomas of the skin
- No planned surgery over the duration of the study
- Participants must be willing to come to the site each week for 16 weeks to receive the treatment and then monthly for 3 visits during the follow up period
Polymyalgia Rheumatica [CAIN457C22301]
A randomised, parallel-group, double-blind, placebo-controlled, multicentre Phase 3 trial to evaluate efficacy and safety of secukinumab administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with polymyalgia rheumatica.
(PMR)
Protocol CAIN457C22301:
- Male or female participants at least 50 years of age
- Established diagnosis of PMR and appropriate treatment of at least 8 consecutive weeks with prednisone at any time
- At least 1 episode of PMR relapse while attempting to decrease prednisone within the last 12 weeks
- No evidence of Giant Cell Arteritis permitted
- No previous exposure to to bDMARDs permitted
- Active inflammatory bowel disease not permitted
- Study duration is 12 months with the option of an extension study if there is a relapse during the treatment fee period
- Visits to site start weekly for the 1st month and thereafter monthly
Systemic Lupus Erythematosus [M23-699]
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 M23-699:
- 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 [M23-700]
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 M23-700:
- 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 [CA42750]
A phase 3, randomised, double-blind, placebo-controlled, multicentre study to evaluate the efficacy and safety of obinutuzumab in patients with systemic lupus erythematosus
Protocol CA42750:
- Male or female participants between the ages of 18 – 75 years of age
- Established diagnosis of SLE for at least 12 weeks
- Positive results for ANA or anti-dsDNA and/or Anti-Sm antibodies, required
- Low complement levels, required
- High disease activity required ( current active SLE manifestations)
- Treatment with at least 1 of the following – prednisone, plasmoquine and/or Methotrexate, MMF, azathioprine
- Pregnancy and breastfeeding is excluded
- History of cancer within the last 5 years
- Study participation is for 2 years and the option of continued used of the active medication thereafter
- Treatment is administered intravenously at Week’s 0,2 ,24 ,26 ,54 ,56 ,78 & 104
- Visits to the clinical trial site are scheduled monthly for the 1st year, thereafter less
frequently
Systemic Lupus Erythematosus [CVAY736F12301]
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 CVAY736F12301:
- 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
