ong-term study of BI695501 in patients with active rheumatoid arthritis

Phase 1

Conditions: Rheumatoid arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2015-002634-41-BG

Lead Sponsor: Boehringer Ingelheim International GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

1. All patients must sign and date an Informed Consent Form consistent with ICH 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.
2. 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.
3. Patients willing and able to self-administer BI 695501 pre-filled syringe.
4. For participants of reproductive potential (males and females), a reliable means of contraception has to be used throughout trial participation. Acceptable methods of birth control include, for example, birth control pills, intrauterine devices, surgical sterilization, vasectomized partner and double barrier method (for example male condom in combination with female diaphragm/cervical cap plus spermicidal foam/gel/film/cream/suppository). All patients (males and females of child-bearing potential) must also agree to use an acceptable method of contraception for 6 months following completion or discontinuation from the trial medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 265
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 135

Exclusion Criteria

1. Patients who experienced Investigator-reported drug-related serious adverse events (SAEs) in Trial 1297.2.
2. ACR functional Class IV or wheelchair/bed bound.
3. Primary or secondary immunodeficiency (history of, or currently active).
4. Positive QuantiFERON test.
5. Known clinically significant coronary artery disease or significant cardiac arrhythmias or severe congestive heart failure (New York Heart Association Classes III or IV), or interstitial lung disease observed on chest X-ray.
6. Anaphylactic reaction or hypersensitivity to adalimumab received in Trial 1297.2.
7. History or recent evidence of cancer including solid tumors, hematologic malignancies, and carcinoma in situ (except participants with previous resected and cured basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ Grade I cervical cancer within 5 years prior to the Screening Visit).
8. Positive serology for HBV or hepatitis C virus (HCV).
9. Patients who are expecting to receive any live virus or bacterial vaccinations during the trial, or up to 3 months after the last dose of trial drug.
10. Any treatment (including biologic therapies) that, in the opinion of the Investigator, may place the patient at unacceptable risk during the trial.
11. Patients with a significant disease other than RA and/or a significant uncontrolled disease
12. Premenopausal (last menstruation 1 year prior to screening), sexually active women who are pregnant or nursing, or are of child-bearing potential and not practicing an acceptable method of birth control, or do not plan to continue practicing an acceptable method of birth control throughout the trial (acceptable methods of birth control are intrauterine
devices, surgical sterilization, double barrier, or vasectomized partner).
13. Current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, pulmonary fibrosis, or Felty’s syndrome, scleroderma, inflammatory myopathy, mixed connective tissue disease, or any overlap syndrome). Secondary Sjögren’s syndrome or secondary limited cutaneous vasculitis with RA is permitted.
14. Any planned surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) for the duration of the trial.
15. Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with intravenous (i.v.) anti-infectives within 4 weeks of the Screening Visit or completion of oral anti-infectives within 2 weeks of the Screening Visit.
16. Serious infection or opportunistic infection during the 1297.2 trial.
17. 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.
18. Currently active alcohol or drug abuse.
19. Treatment with i.v. Gamma Globulin or the Prosorba® Column during the 1297.2 trial.
20. Planned treatment with i.v. intramuscular, intra-articular and parenteral corticosteroids.
21. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times upper
limit of normal (ULN).
22. Hemoglobin <8.0 g/dL.
23. Platelets <100,000/µL.
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Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this trial is to provide long-term safety, efficacy, PK, and immunogenicity data on BI 695501 administered via prefilled syringe in patients with RA who have completed Trial 1297.2 (EudraCT no. 2012-002945-40).;Secondary Objective: Long-term efficacy will be assessed as a secondary objective in this trial.;Primary end point(s): The primary endpoint is the number (proportion) of patients with drug-related AEs (Adverse Events) during the treatment phase;Timepoint(s) of evaluation of this end point: The primary endpoint of this trial will be evaluated during the treatment phase of 48 Weeks. All AEs with an onset date between start of treatment and end of the REP (Residual effect period, after the last dose of medication with measureable drug levels or pharmacodynamic effects still likely to be present), a period of 10 weeks after the last dose of trial medication, will be assigned to the treatment phase for evaluation.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Long-term efficacy will be assessed as a secondary objective in this trial:<br>- The change from Baseline in DAS28 (ESR) <br>- The proportion of patients meeting ACR20 response criteria <br>- The proportion of patients who meet the ACR/European League Against Rheumatism (EULAR) definition of remission <br>- The proportion of patients with EULAR response (good response, moderate response, or no response) ;Timepoint(s) of evaluation of this end point: Week 48

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