Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: BI 695501
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 430.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The main objective of this trial is to provide long-term safety, pharmacokinetics (PK), and
      immunogenicity data on BI 695501 administered via prefilled syringe in patients with
      Rheumatoid Arthritis who have completed Trial 1297.2. The primary endpoint thereby is the
      number (proportion) of patients with drug-related adverse events (AEs) during the treatment
      phase. The secondary objective in this trial is the assessment of Long-term efficacy of BI
      695501 by evaluation of:

        -  the change from Baseline in DAS28 (ESR) at Week 48

        -  the proportion of patients meeting American College of Rheumatology 20% (ACR20) response
           criteria at Week 48

        -  the proportion of patients who meet the American College of Rheumatology (ACR)/European
           League Against Rheumatism (EULAR) definition of remission at Week 48

        -  the proportion of patients with EULAR response (good response, moderate response, or no
           response) at Week 48.
    

Eligibility criteria:

        Inclusion criteria:

          -  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).

        Exclusion criteria:

          -  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