PRA-177981 Multiple Sclerosis (MS) € 3.075,-

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Description

Study of a registered compound in the treatment of Multiple Sclerosis (MS)

Requested participants

  • M/F, gezond, 18 - 65 years old

Duration and visits

  • 4 days stay
  • 12 short visits

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Research details

Particulars

  • Your body weight must be between 50 and 110 kg and your Body Mass Index (BMI) is between 18.5 and 32.0 kg/m2. The BMI shows the relation between body weight in kilograms and height in meters.
  • Both non-smokers and light smokers are allowed to participate in this study; however, during your stay in the research facility, smoking is not allowed.
  • Women are only allowed to participate in this study if they are using sufficient contraception (such as hormonal contraceptives combined with a condom) or if they have been postmenopausal for at least one year or if they have been surgically sterilized.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening. The medical screening for this study will consist of two visits. During the first screening visit we will take 2 blood samples to evaluate the presence of antibodies against the registered compound and John Cunningham Virus (JCV). If it turns out that you are not a carrier of this virus and there are no antibodies against the compound, the remainder of the medical screening will be conducted during the second visit.
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Compensation

You will receive a gross compensation of € 3.075,- for participation in one of the groups of this study. This compensation includes the compensation for the first visit of the medical screening.

If, based on the first visit of the medical screening, it turns out that you are a carrier of the JC virus or that there are antibodies against the compound present (and you will be rejected for this study based on this result) you will receive a gross compensation of €25,- for the first visit.

Travelling expenses will be reimbursed based on the distance traveled (€0,19 net per kilometer) with a minimum of €12,- and a maximum of €160,- (840 kilometers) per return, regardless of the mode of transportation.

Period of stay and research

The study consists of 1 period during which you will stay in our research facility in Groningen (UMCG site) for 4 days (3 nights), followed by 12 short visits to our research facility (Martini site). The follow-up will take place during the second to last short visit. During the last short visit, a physical examination and vital signs measurement will be done.

Please note: You have to be available for all dates for the group of choice to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.

 

About Multiple Sclerosis

Multiple Sclerosis is a disease in which the protective and insulating layer around the nerves in the brain, spinal cord and optic nerves (the central nervous system) is damaged. As a result, problems with walking, feeling and seeing can occur.

Information sheet PRA-177981

Type of study

The purpose of the study is to investigate how quickly and to what extent different doses of the drug are absorbed and eliminated of the body and how the body responds to different doses. The study will assess the safety profile of the registered drug at different doses. The sponsor is developing a compound similar to the registered drug. In preparation for medical-scientific studies to confirm the similarity of the compounds, the sponsor wants to study the effect of different doses of the registered drug on the body.

The study will only take place after it has been approved by the Independent Ethics Committee

Setup and duration of the study

The actual study will consist of 1 period during which you will stay in the clinical research center in Groningen (UMCG site) for 4 days (3 nights). This period will be followed by 11 short visits to the clinical research center (Martini site). Prior to the study you will visit the medical screening center in Groningen on two occasions. During the first screening visit we will take 2 blood samples to evaluate the presence of antibodies against the registered drug and John Cunningham Virus (JCV). During the second screening visit, the remaining part of the medical screening (consisting of, amongst others, a physical examination, measurement of your weight, height, blood pressure, heart rate and body temperature and making a heart tracing) will be conducted. You will also visit the medical screening center once after the study.

You will receive the drug once via an intravenous infusion of 60 minutes in 1 of 3 predetermined doses. Which dose you will receive will be determined by chance.

Risks and medical supervision

The drug is approved in the EU for the treatment of MS. MS causes inflammation in the brain that damages the nerve cells. The active ingredient of the registered drug is called a monoclonal antibody. These antibodies work by binding to proteins in the body so that the harmful effect of that protein is removed. The registered drug stops the cells that cause inflammation from going into the brain. This reduces nerve damage caused by MS.

As with any medicine, the registered drug may cause side effects, although not everybody gets them. The most common reported (in up to 1 in 10 people) side effects are: urinary tract infection, sore throat and runny or congested nose, shivering, itchy rash (hives), headache, dizziness, feeling sick (nausea), being sick (vomiting), joint pain, fever, tiredness. You will be under strict medical supervision during the study.

Conditions for participation

You are a healthy male or female between 18 and 65 years old. You can only take part in the study if you do not smoke or if you are a light smoker. Women are only allowed to participate in this study if they are using sufficient contraception (such as hormonal contraceptives combined with a condom) or if they have been postmenopausal for at least one year or if they have been surgically sterilized.

The study will be executed under standardized conditions. Use of your own medication, alcohol, regular coffee and tea, cola, power drinks, chocolate (including products made of chocolate) and grapefruit (juice) during the study is not allowed. Also before the study there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine is allowed. Before you are allowed to take part in the study, you will be medically screened; this screening will take place within eight weeks before the start of the study.

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Group 6

€ 3.075,-

4 days stay

  • 28 Jun 2018 up to and including 1 Jul 2018

short stay

Inapplicable

short visit

  • 3 Jul 2018
  • 6 Jul 2018
  • 13 Jul 2018
  • 20 Jul 2018
  • 27 Jul 2018
  • 3 Aug 2018
  • 10 Aug 2018
  • 24 Aug 2018
  • 7 Sep 2018
  • 14 Sep 2018
  • 21 Sep 2018
  • 14 Dec 2018

Group 1

€ 3.075,-

4 days stay

  • 11 Jun 2018 up to and including 14 Jun 2018

short stay

Inapplicable

short visit

  • 16 Jun 2018
  • 19 Jun 2018
  • 26 Jun 2018
  • 3 Jul 2018
  • 10 Jul 2018
  • 17 Jul 2018
  • 24 Jul 2018
  • 7 Aug 2018
  • 21 Aug 2018
  • 28 Aug 2018
  • 4 Sep 2018
  • 27 Nov 2018
Group full

Group 2

€ 3.075,-

4 days stay

  • 14 Jun 2018 up to and including 17 Jun 2018

short stay

Inapplicable

short visit

  • 19 Jun 2018
  • 22 Jun 2018
  • 29 Jun 2018
  • 6 Jul 2018
  • 13 Jul 2018
  • 20 Jul 2018
  • 27 Jul 2018
  • 10 Aug 2018
  • 24 Aug 2018
  • 31 Aug 2018
  • 7 Sep 2018
  • 30 Nov 2018
Group full

Group 3

€ 3.075,-

4 days stay

  • 18 Jun 2018 up to and including 21 Jun 2018

short stay

Inapplicable

short visit

  • 23 Jun 2018
  • 26 Jun 2018
  • 3 Jul 2018
  • 10 Jul 2018
  • 17 Jul 2018
  • 24 Jul 2018
  • 31 Jul 2018
  • 14 Aug 2018
  • 28 Aug 2018
  • 4 Sep 2018
  • 11 Sep 2018
  • 4 Dec 2018
Group full

Group 4

€ 3.075,-

4 days stay

  • 21 Jun 2018 up to and including 24 Jun 2018

short stay

Inapplicable

short visit

  • 26 Jun 2018
  • 29 Jun 2018
  • 6 Jul 2018
  • 13 Jul 2018
  • 20 Jul 2018
  • 27 Jul 2018
  • 3 Aug 2018
  • 17 Aug 2018
  • 31 Aug 2018
  • 7 Sep 2018
  • 14 Sep 2018
  • 7 Dec 2018
Group full

Group 5

€ 3.075,-

4 days stay

  • 25 Jun 2018 up to and including 28 Jun 2018

short stay

Inapplicable

short visit

  • 30 Jun 2018
  • 3 Jul 2018
  • 10 Jul 2018
  • 17 Jul 2018
  • 24 Jul 2018
  • 31 Jul 2018
  • 7 Aug 2018
  • 21 Aug 2018
  • 4 Sep 2018
  • 11 Sep 2018
  • 18 Sep 2018
  • 11 Dec 2018
Group full

Group 7

€ 3.075,-

4 days stay

  • 2 Jul 2018 up to and including 5 Jul 2018

short stay

Inapplicable

short visit

  • 7 Jul 2018
  • 10 Jul 2018
  • 17 Jul 2018
  • 24 Jul 2018
  • 31 Jul 2018
  • 7 Aug 2018
  • 14 Aug 2018
  • 28 Aug 2018
  • 11 Sep 2018
  • 18 Sep 2018
  • 25 Sep 2018
  • 18 Dec 2018

Group 8

€ 3.075,-

4 days stay

  • 5 Jul 2018 up to and including 8 Jul 2018

short stay

Inapplicable

short visit

  • 10 Jul 2018
  • 13 Jul 2018
  • 20 Jul 2018
  • 27 Jul 2018
  • 3 Aug 2018
  • 10 Aug 2018
  • 17 Aug 2018
  • 31 Aug 2018
  • 14 Sep 2018
  • 21 Sep 2018
  • 28 Sep 2018
  • 21 Dec 2018

Group 9

€ 3.075,-

4 days stay

  • 9 Jul 2018 up to and including 12 Jul 2018

short stay

Inapplicable

short visit

  • 14 Jul 2018
  • 17 Jul 2018
  • 24 Jul 2018
  • 31 Jul 2018
  • 7 Aug 2018
  • 14 Aug 2018
  • 21 Aug 2018
  • 4 Sep 2018
  • 18 Sep 2018
  • 25 Sep 2018
  • 2 Oct 2018
  • 25 Dec 2018

Group 10

€ 3.075,-

4 days stay

  • 12 Jul 2018 up to and including 15 Jul 2018

short stay

Inapplicable

short visit

  • 17 Jul 2018
  • 20 Jul 2018
  • 27 Jul 2018
  • 3 Aug 2018
  • 10 Aug 2018
  • 17 Aug 2018
  • 24 Aug 2018
  • 7 Sep 2018
  • 21 Sep 2018
  • 28 Sep 2018
  • 5 Oct 2018
  • 28 Dec 2018

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