Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Arthritis, Rheumatoid

Treatments

Drug: BI 695501

Study type

Interventional

Funder types

Industry

Identifiers

NCT02640612

2015-002634-41 (EudraCT Number)

1297.3

Details and patient eligibility

About

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.

Enrollment

430 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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