Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
All patients must sign and date an Informed Consent Form consistent withInternational Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local legislation prior to participation in the trial (i.e., prior to any trial procedures, which include medication washout and restrictions) and be willing to follow the protocol.
Adult patients with moderately to severely active RA who have completed Trial 1297.2, and who wish to participate in this extension trial and in the investigator´s assessment can benefit from receiving BI 695501.
Patients willing and able to self-administer BI 695501 pre-filled syringe.
Willing to use a reliable means of contraception throughout trial participation (females) and willing to use an acceptable method of contraception for 6 months following completion or discontinuation from the trial medication males and females).
You may not be if
Investigator-reported drug-related Serious Adverse Events (SAEs) in Trial 1297.2
ACR functional Class IV or wheelchair/bed bound
Primary or secondary immunodeficiency (history of, or currently active)
Positive QuantiFERON test
Known clinically significant coronary artery disease or significant cardiac arrhythmias or severe congestive heart failure (NYHA Classes III / IV), or interstitial lung disease
Anaphylactic reaction or hypersensitivity to adalimumab in Trial 1297.2
History / recent evidence of cancer incl. solid tumours, hematologic malignancies, and carcinoma in situ (certain exceptions permitted)
Positive serology for Hepatitis B virus (HBV) or Hepatitis C virus (HCV)
Planned live virus or bacterial vaccinations during the trial, or up to 3 months after the last dose of trial drug
Receipt or treatment (including biologic therapies) that may place the patient at unacceptable risk during the trial
Significant disease (disease which may (i) put the patient at risk because of participation or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial) other than RA and/or a significant uncontrolled disease
Women: premenopausal (last menstruation 1 year prior to screening), sexually active, pregnant or nursing, or of child-bearing potential and not practicing an acceptable method of birth control, or not planning to use an acceptable method of birth control throughout the trial
Current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, etc.) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, pulmonary fibrosis, etc.). Secondary Sjögren´s syndrome or secondary limited cutaneous vasculitis with RA is permitted
Any planned surgical procedure, including bone/joint surgery/synovectomy for the duration of the trial
Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with iv. anti-infectives within 4 weeks of the Screening Visit or completion of oral anti-infectives within 2 weeks of the Screening Visit
Serious infection or opportunistic infection during the 1297.2 trial
Any acquired neurological, vascular, systemic or demyelinating disorder that might affect any of the efficacy assessments, in particular, joint pain and swelling (e.g., Parkinson´s disease, cerebral palsy, diabetic neuropathy) that occurred during the 1297.2 trial.
Currently active alcohol or drug abuse
Treatment with iv. Gamma Globulin or the Prosorba® Column during the 1297.2 trial
Planned treatment with iv. intramuscular, intra-articular and parenteral corticosteroids
Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \>1.5 times upper limit of normal (ULN)
Hemoglobin \<8.0 g/dL
Platelets \<100,000/µL
Leukocyte count \<4000/µL
Creatine clearance \<60 mL/min
Current participation in another clinical trial
Clareo Health | Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis
