PRA-170071 Rheumatoid Arthritis and Psoriasis € 2.530,-

Full

Description

Study of a new formulation of a registered drug that is being developed for the treatment of autoimmune diseases (for example for rheumatoid arthritis and psoriasis)

Requested participants

  • Male, healthy , 18 - 55 years old
  • Non-smokers only

Duration and visits

  • 2 times 7 days stay
  • 11 short visits

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Research details

Particulars

  • For this study we are looking for healthy males, between 18 and 55 years old who do not smoke.
  • Your Body Mass Index (BMI) is between 19 and 29.9 kg/m2 and your body weight is between 50 – 99.9 kg. The BMI shows the relation between body weight in kilograms and height in meters.
  • You did not participate in one of the following studies with PRA code: 120711, 134391, 166721, 142461 and 164911.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening visit.
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Compensation

You will receive a gross compensation of €2530,- for complete participation in one of the groups of this study.  


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 2 periods. For each period you will stay in our research facility in Groningen (location Martini) for 7 days (6 nights). The first period will be followed by 5 short visits and the second period by 6 short visits.

Please note: You must 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.

Information sheet PRA-170071

Type of study

Soon, a research study will start at PRA with a new formulation of a registered study drug that is being developed for the treatment of autoimmune diseases (for example for rheumatoid arthritis and psoriasis). This study will compare the study drug to a similar product which is already on the market in US referred to as comparator drug.  The study drug and the comparator drug contain the same active ingredient.

The purpose of the study is to compare these two drugs in view of how quickly and to what extent the drugs are absorbed and eliminated from the body (this is called pharmacokinetics) after injection under the skin of the abdomen. In addition, it will be analysed to which degree the study drug is provoking an immune response. It will also be investigated how safe the study drug is and how well it is tolerated after dosing. This study is the first time that this new form of the study drug is being given to humans.

The – study drug is no new drug; it is already available on the market in several dosages as a pre filled syringe, but not in a dose-adjustable vial for injection (e.g. for paediatric patients who weigh less than 63 kilograms). The other already registered drug is already available as dose-adjustable vial for injection in the treatment of autoimmune diseases in children.

This study will be performed in 56 healthy male volunteers. The study will only take place after it has been approved by the Independent Ethics Committee

Setup and duration of the study

To determine if you are suitable to participate in this study, you will undergo a medical screening visit. Following the screening visit, if you are eligible for participation, the study consists of 2 periods in which you will stay in our research facility in Groningen (location Martini) for 7 days (6 nights) for each period. The first period will be followed by 5 short visits and the second period by 6 short visits. Blood samples will be taken regularly during the study.

During the study, you will receive the study drug and the registered drug as an injection under the skin (subcutaneous) of your abdomen. The order in which you will receive the study drug and the registered drug will be determined by chance. Between the two dosing’s a wash-out of at least 35 days is necessary.

Risks and medical supervision

All drugs can potentially cause adverse reactions; the extent to which this occurs differs. The most common known side effects of the study drug and the comparator drug include the following:

Very common (may affect more than 1 in 10 people):

Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections);

Injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling).

Reactions at the injection site (these do not occur as often after the first month of treatment). Some patients have developed a reaction at an injection site that was used before.

Common (may affect up to 1 in 10 people):

Allergic reactions; fever; itching; antibodies directed against normal tissue (autoantibody formation).

More information about the more uncommon side effects can be found in the Informed Consent Form that can be found in the package leaflet which will be handed out to you before and during the screening for this study.

You should be aware that the adverse events mentioned above and possibly other, still unknown, adverse events may occur during the study.  You will be under strict medical supervision during the study.

Conditions for participation

You are a healthy male between 18 and 55 years old. You are only allowed to participate if you do not smoke. Your Body Mass Index (BMI) is between 19 and 29.9 kg/m2 and your body weight is between 50 – 99.9 kg. The BMI shows the relation between body weight in kilograms and height in meters. You did not participate in one of the following studies with PRA code: 120711, 134391, 166721, 142461, and 164911.

The study will be done under standardized conditions. Use of alcohol, poppy seeds and tobacco products 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. During this screening, the study doctor will discuss with you if any of the medications you were or you are still using could prevent you from participating in the study.

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Group 11

€ 2.530,-

2 times 7 days stay

  • 4 Nov 2018 up to and including 10 Nov 2018
  • 9 Dec 2018 up to and including 15 Dec 2018

short stay

Inapplicable

short visit

  • 12 Nov 2018
  • 14 Nov 2018
  • 16 Nov 2018
  • 19 Nov 2018
  • 23 Nov 2018
  • 17 Dec 2018
  • 19 Dec 2018
  • 21 Dec 2018
  • 24 Dec 2018
  • 28 Dec 2018
  • 7 Jan 2019
Group full

Group 12

€ 2.530,-

2 times 7 days stay

  • 6 Nov 2018 up to and including 12 Nov 2018
  • 12 Dec 2018 up to and including 18 Dec 2018

short stay

Inapplicable

short visit

  • 14 Nov 2018
  • 16 Nov 2018
  • 18 Nov 2018
  • 21 Nov 2018
  • 25 Nov 2018
  • 20 Dec 2018
  • 22 Dec 2018
  • 24 Dec 2018
  • 27 Dec 2018
  • 31 Dec 2018
  • 10 Jan 2019
Group full

Group 13

€ 2.530,-

2 times 7 days stay

  • 11 Nov 2018 up to and including 17 Nov 2018
  • 6 Jan 2019 up to and including 12 Jan 2019

short stay

Inapplicable

short visit

  • 19 Nov 2018
  • 21 Nov 2018
  • 23 Nov 2018
  • 26 Nov 2018
  • 30 Nov 2018
  • 14 Jan 2019
  • 16 Jan 2019
  • 18 Jan 2019
  • 21 Jan 2019
  • 25 Jan 2019
  • 4 Feb 2019
Group full

Group 14

€ 2.530,-

2 times 7 days stay

  • 13 Nov 2018 up to and including 19 Nov 2018
  • 8 Jan 2019 up to and including 14 Jan 2019

short stay

Inapplicable

short visit

  • 21 Nov 2018
  • 23 Nov 2018
  • 25 Nov 2018
  • 28 Nov 2018
  • 2 Dec 2018
  • 16 Jan 2019
  • 18 Jan 2019
  • 20 Jan 2019
  • 23 Jan 2019
  • 27 Jan 2019
  • 6 Feb 2019
Group full

Group 15

€ 2.530,-

2 times 7 days stay

  • 18 Nov 2018 up to and including 24 Nov 2018
  • 13 Jan 2019 up to and including 19 Jan 2019

short stay

Inapplicable

short visit

  • 26 Nov 2018
  • 28 Nov 2018
  • 30 Nov 2018
  • 3 Dec 2018
  • 7 Dec 2018
  • 21 Jan 2019
  • 23 Jan 2019
  • 25 Jan 2019
  • 28 Jan 2019
  • 1 Feb 2019
  • 11 Feb 2019
Group full

Group 16

€ 2.530,-

2 times 7 days stay

  • 20 Nov 2018 up to and including 26 Nov 2018
  • 15 Jan 2019 up to and including 21 Jan 2019

short stay

Inapplicable

short visit

  • 28 Nov 2018
  • 30 Nov 2018
  • 2 Dec 2018
  • 5 Dec 2018
  • 9 Dec 2018
  • 23 Jan 2019
  • 25 Jan 2019
  • 27 Jan 2019
  • 30 Jan 2019
  • 3 Feb 2019
  • 13 Feb 2019
Group full

Group 17

€ 2.530,-

2 times 7 days stay

  • 25 Nov 2018 up to and including 1 Dec 2018
  • 20 Jan 2019 up to and including 26 Jan 2019

short stay

Inapplicable

short visit

  • 3 Dec 2018
  • 5 Dec 2018
  • 7 Dec 2018
  • 10 Dec 2018
  • 14 Dec 2018
  • 28 Jan 2019
  • 30 Jan 2019
  • 1 Feb 2019
  • 4 Feb 2019
  • 8 Feb 2019
  • 18 Feb 2019
Group full

Group 18

€ 2.530,-

2 times 7 days stay

  • 27 Nov 2018 up to and including 3 Dec 2018
  • 22 Jan 2019 up to and including 28 Jan 2019

short stay

Inapplicable

short visit

  • 5 Dec 2018
  • 7 Dec 2018
  • 9 Dec 2018
  • 12 Dec 2018
  • 16 Dec 2018
  • 30 Jan 2019
  • 1 Feb 2019
  • 3 Feb 2019
  • 6 Feb 2019
  • 10 Feb 2019
  • 20 Feb 2019
Group full

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