Rheumatoid Arthritis - Clinical Trial with Simbec Orion

If you are a male or female aged between 18 and 75 with a confirmed diagnosis of Rheumatoid Arthritis (RA) for at least three months, you may be eligible to participate in a study investigating a new drug for the treatment of RA.

To qualify, you must be receiving ongoing treatment with at least one or two of the following medications for a minimum of 12 weeks: Methotrexate, Hydroxychloroquine, Chloroquine, Sulfasalazine, or Leflunomide.

Study Payment* £1,887.

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*Terms & Conditions apply.

Study Payment: £1,887

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By agreeing to this form and selecting the box as outlined below, you are confirming that you have read the information provided in our data protection and consent policy, and give your consent for Simbec-Orion to record and retain your personal and special categories of data for the purposes and duration(s) stated in our policy linked above.

Please confirm that you have read these terms and understand that Simbec-Orion will be holding and processing your personal and special categories of data for the purposes stated in our policy linked above.

Simbec-Orion are also required to process your bio-metric data (a photograph only when you attend an onsite screening visit), we do this to ensure we can identify you for security purposes. We do not share this data with any other third-party, we solely use this data for the purpose of recognition. For the completion of your enrolment and part of your eligibility, we are required to collect this data. By selecting the box below, you also explicitly consent to the use of your bio-metric data as and when it is collected.

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Thank you for your time and interest, but unfortunately based on your answer, you are not eligible to apply for this part of the study.

Please register with our database as we may have studies in the near future which require the participation of people diagnosed with Rheumatoid arthritis register here This way we can be in contact as soon as you are eligible for another trial of this nature .

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Study Information

Simbec-Orion Clinical Pharmacology are running a two-part study to investigate the study drug, GS-0272 in participants with Rheumatoid Arthritis (RA). This study will be split into two separate parts (Part A and Part B). Note: Recruitment and Screening for Part B is currently open.

This study drug is being developed for the treatment of Rheumatoid Arthritis (RA). RA is a type of autoimmune and inflammatory disease whereby the immune system of the body becomes dysfunctional and starts to attack the body itself, damaging cells and organs instead of performing its normal function of protecting the body from infection and disease caused by bacteria and viruses etc. This leads to increased inflammation which is a protective response that is critical in initiating repair in the body. Currently, there are limited treatment options available for RA which are considered long term and effective and there are no known cures. Therefore, there is an unmet need to develop potential new treatments which could be more effective.

The main objectives of the second part of this study (Part B) are as follows:

To investigate the effect of the study drug on the body by analysing the levels of certain biomarkers* in the body and will evaluate the immune system response to the study drug through the measurement of anti-drug antibodies**.

To determine the safety and tolerability when it is administered as multiple doses once every 2 weeks over a period of up to 12 weeks.

To investigate the concentration in the blood and how this changes over a period of time when it is administered as multiple doses once every 2 weeks over a period of up to 12 weeks.

*Biomarkers are markers within the body such as a gene, molecule or characteristic which can be used to identify the presence of a particular biological process occurring in the body or a particular disease.

**Anti-drug antibodies are proteins which can result in an immune response which prevents the study drug from having its’ desired effect in the body. As well as evaluating the above, the study will also investigate the efficacy of the study drug by measuring any changes/improvements in markers of disease activity for RA.

Samples will be taken at set timepoints throughout each part of the study in order to measure the levels of the study drug and how these change over time, in addition to measurement of the markers described. The results from each of the groups and each study part will be analysed in order to better understand how the study drug works in the body and the effectiveness of the study drug in patients with RA.

If you require any further information or would like to speak with a member of the team before applying please see contact details at the bottom of this page. On successful application you will receive the full clinical study information sheet and consent form, to aid any questions and queries you may have about participating in this trial.

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Part B – Purpose and Timeline

The purpose of Part B is to evaluate the study objectives when GS-0272 is administered once every 2 weeks over a period of 12 weeks at a set dose strength (up to 800 mg). Part B will consist of up to 51 participants which may be split into two groups; a safety lead in group of 9 participants and then a remaining group of 42 participants (Simbec-Orion are only participating in the Part B main group). Each participant will receive the study drug or a placebo (which contains no active drug) in the form of either an intravenously or subcutaneously.

You will not be required to stay overnight at the clinical unit for any of the visits, these are all single day visits whereby you may be required to be at the clinical unit for up to 8 hours. You should ensure that you are available to complete all required visits before agreeing to participate in the study.

If you participate in this study, you will be required to attend a series of day visits at the clinical unit as follows:

Dosing Visits – Day 1, Day 15, Day 29, Day 43, Day 57, Day 71 & Day 85.

Return Visits – Day 5, Day 89, Day 99, Day 113, Day 141, Day 169 & Day 197.

You should ensure that you are able to commit to completing all visits before agreeing to participate in this study.

If you participate in this part of the study, you will receive an inconvenience payment for the inconvenience of participating in and satisfactorily completing the study including all procedures and the post-study follow up visit, along with the highest level of compliance.

The level of payment you receive will be split across the study where you will receive set payments following completion of all visits up to a certain point which will amount to the overall total payment quoted below. The below table shows the inconvenience payment for the study and how this will be split based upon the factors described above.

Screening Visit: £119
Day 1 up to Day 29: £527
Day 29 up to Day 57: £238
Day 57 up to Day 89: £408
Day 89 up to Day 113: £238
Day 113 up to Day 141: £119
Day 141 up to Day 197: £238

Total Inconvenience Payment: £1887 (sum of all totals listed above)

Screening Visit
Day -29 to Day -2

Dosing Visits

Day 1, Day 15, Day 29, Day 43, Day 57, Day 71 & Day 85

Return Visits

Day 5, Day 89, Day 99, Day 113, Day 141, Day 169 & Day 197

Apply Now. Be Amazing

Clinical Study Rheumatoid Arthritis

If you are a male or female aged between 18 and 75 with a confirmed diagnosis of Rheumatoid Arthritis (RA) for at least three months, you may be eligible to participate in a study investigating a new drug for the treatment of RA.

Study Payment* £1,887.

Your details

Study Information

Let's get started