Status:
COMPLETED
Study of an Anti-TLR4 mAb in Rheumatoid Arthritis
Lead Sponsor:
Light Chain Bioscience - Novimmune SA
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2, PoC, randomized, placebo-controlled, double blind, international multicentre study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis
Detailed Description
The study foresees the randomization of at least 81 moderate to severe, ACPA positive, RA patients who are inadequate responders to MTX, in two double blind arms (NI-0101:placebo, with a ratio of 2:1)...
Eligibility Criteria
Inclusion
- Male and female patients
- Age \>= 18 years old
- BMI: \< 30 and \> 18
- Diagnosis of RA according to 2010 ACR/EULAR criteria and with a disease duration of at least 6 months since diagnosis
- Patient must present with active RA, characterized by at least 6 swollen joints out of 66 assessed and 6 tender joints out of 68 assessed and by the presence of synovitis (measured by ultrasound) in at least one of the 6 swollen joints
- C-reactive protein (CRP) level \> 0.7 mg/dL or if the CRP level is between 0.3 mg/dL and 0.7 mg/dL (included) then patient must also present an ESR \> 30mm/hr
- Patients must have received MTX treatment for at least 3 months and have been on a stable dose of MTX for at least 6 weeks prior to start of screening
- ACPA-positive RA patients
- Women must be postmenopausal (\> 12 months without menses) or surgically sterile or using two effective contraception methods for at least 4 weeks prior to the randomization date and agree to continue contraception for the duration of their participation in the study (until the end of follow up period)
- Sexually active male patients must use a barrier method of contraception during the course of the study (and until the end of the follow up period)
- Patients must give written informed consent for study participation
Exclusion
- A documented history of an autoimmune disease other than RA by ACR classification, or Sjögren syndrome
- Administration of cytotoxic drugs and immune suppressants (other than MTX) within 3 months prior to screening
- Previous multiple administrations of any biological DMARD or targeted synthetic DMARD
- Known primary immunodeficiency
- Pregnant or breastfeeding women
- Suspicion of active or latent tuberculosis
- HIV, HCV, HBV infection
- Infection reported during screening not recovered 72h prior to first dose
- History of anaphylactic reactions to any protein therapeutics or excipients
- Any history of malignancy, excluding cured basal or squamous cell carcinoma of the skin, or cervical in situ carcinoma
- Clinically significant cardiac disease requiring medication, such as congestive heart failure, unstable angina, myocardial infarction within 6 months prior to randomization
- Moderate to severe renal insufficiency, clinically relevant liver function test abnormalities or pancytopenia
- Major psychiatric or neurological disorder
Key Trial Info
Start Date :
May 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2018
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03241108
Start Date
May 10 2017
End Date
June 20 2018
Last Update
August 14 2018
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinic for internal medicine with centre for dialysis
Mostar, Bosnia and Herzegovina, 88000
2
Multi-profile Hospital for Active Treatment "Trimontsium"
Plovdiv, Bulgaria, 4000
3
University Multiprofile Hospital for Active Treatment "Kaspela"
Plovdiv, Bulgaria, 4001
4
Multiprofile Hospital for Active Treatment - Shumen AD
Shumen, Bulgaria, 9705