Study record managers: refer to the Data Element Definitions if submitting registration or results information. Experimental: Certolizumab pegol mg Participants received mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was weeks. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event.
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Tuberculosis, other infection such as blood infection, a chronic infection or a history of recurrent infection. Moderate to severe heart failure. Do not use CIMZIA if the packaging is torn or shows signs of tampering or if the pre-filled syringe or pen does not look quite right. Setting up.
Choosing and preparing an injection site. Throwing away supplies. Consumer Medicine Information. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again. Rheumatoid arthritis. Rheumatoid arthritis is an inflammatory disease of the joints. Symptoms include joint pain, tenderness, swelling and stiffness. Psoriatic arthritis is an inflammatory disease of the joints and skin, with similarities to rheumatoid arthritis as well as psoriasis.
Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis. Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis are inflammatory diseases of the spine.
Symptoms include back pain and morning stiffness. Plaque psoriasis is an inflammatory disease of the skin.
Symptoms include red, itchy and inflamed skin. Monoclonal antibodies are proteins that recognise and bind to other unique proteins. CIMZIA is normally used together with another medicine called methotrexate to treat your rheumatoid arthritis. CIMZIA may be used without methotrexate if your doctor determines that it is unsuitable for you to use or continue methotrexate. Symptoms of infection may include:. Before you use it Tell your doctor or pharmacist if you have allergies to:.
Tell your doctor if you have or have had any medical conditions, especially the following:. This will include a thorough medical history, a chest X-ray and a tuberculin test.
Tell your doctor if you are scheduled for any vaccines. Check with your doctor before you receive any vaccines. Tell your doctor if you are scheduled for any surgery. Talk to your doctor if you are going to have any operations or dental procedures.
Tell your doctor if you are pregnant or plan to become pregnant. Tell your doctor if you are breastfeeding or plan to breastfeed. Cimzia can be used during breastfeeding. Taking other medicines Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine. Tell your doctor or pharmacist if you are taking other biologic medicines such as anakinra or abatacept. Taking other biologic medicines while on anti-TNF therapy may increase the risk of infection.
CIMZIA can be taken together with methotrexate, antibiotics, corticosteroids, such as prednisone or pain medications including non-steroidal anti-inflammatory drugs. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the label or in this leaflet, ask your doctor or pharmacist for help. You should check with your doctor or pharmacist if you are unsure. This is followed by a maintenance dose of mg every other week starting at week 6. Alternatively, your doctor may decide that you should receive a monthly dose of mg CIMZIA as 2 injections in one day. Plaque Psoriasis The starting dose is mg CIMZIA as 2 injections in one day given at weeks 0, 2 and 4, then followed by a maintenance dose of either mg every other week or mg every other week starting at week 6.
If you do not understand the instructions on the pack, ask your doctor or pharmacist for help. The injection can be self-administered or given by another person, for example a family member or friend after proper training in injection technique, by your doctor or a nurse. Read the instructions carefully and follow them step by step. Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection. Your doctor or a nurse will show you how to prepare and self-inject.
Do not mix the injection in the same syringe or pen with any other medicine. Wash your hands thoroughly. Set up the following items on a clean surface. One alcohol pad. Do not use the product after the month and year shown.
This will take about 30 minutes for the pre-filled syringe and minutes for the pre-filled pen minutes. Choose a site on your thigh or stomach. Each new injection should be given on a separate site from the last injection site. Do not inject in an area where the skin is tender, reddened, bruised, or hard. Wipe the injection site with the enclosed alcohol pad, using a circular motion. Do not touch the site again before injecting. Do NOT shake the syringe. Check the medicine in the barrel of the syringe is clear to pale yellow and free from particles.
Do not use the pre-filled syringe if the solution is discoloured, cloudy or if you can see particles in it. You may see an air bubble. This is normal. There is no need to remove air bubbles before injection. Injecting the solution subcutaneously with air bubbles is harmless. Remove the cap from needle syringe by pulling off the plastic ring in a straight line, being careful not to touch the needle or let the needle touch any surface. Do not bend the needle.
Hold the syringe with the needle facing down. With one hand, gently grasp the cleaned areas of skin and hold firmly. With the other hand, hold syringe at a 45 degree angle to skin. With one quick, short motion, push the needle all the way into the skin. Push the plunger to inject solution- it can take up to 10 seconds to empty the syringe.
When the syringe is empty, carefully remove the needle from the skin at the same angle at which it was inserted.
Release the skin with the first hand. Using your thumb or a piece of gauze, apply pressure over the injection site for a few seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if necessary. The pre-filled pen is designed to work accurately and safely. Do NOT shake the pre-filled pen. Check the medicine in the pre-filled pen through the viewing window is clear to pale yellow and free from particles.
Do not use the pre-filled pen if the solution is discoloured, cloudy or if you can see particles in it. You may see air bubbles. Hold the pre-filled pen firmly with one hand around the black handle. Grasp the clear cap with the other hand and remove it. Do not twist the cap off as this may jam the internal mechanism. Inject within 5 minutes of removing the cap.
Do not replace the cap. Although hidden from view the needle tip is now uncovered. Do not try to touch the needle as it could activate the pre-filled pen. Press the pre-filled pen firmly against the skin and hold. The injection begins when a first "click" is heard and the orange band at the bottom of the pre-filled pen disappears. Continue to hold the pre-filled pen in place firmly against the skin until a second "click" is heard and the viewing window turns orange.
This can take up to 15 seconds. At this time, the injection will be complete.
Study record managers: refer to the Data Element Definitions if submitting registration or results information. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes RAPID3 ; using a total score of 30 points. CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value CDAI. Lower scores indicate less disease activity.