Rheumatoid Arthritis
Conditions
Brief summary
This is a study to compare the efficacy, safety and immunogenicity of AVT05 versus EU-Simponi® in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA). The study will consist of up to 4-week Screening Period, a 48-week Treatment Period, and a 4-week Safety Follow-up Period.
Interventions
BIOLOGICALAVT05 (proposed biosimilar to golimumab)
AVT05 is a recombinant human IgG1қ mAb developed as a subcutaneous injection
BIOLOGICALSimponi (Golimumab)
Simponi (Golimumab) is a recombinant human IgG1қ mAb developed as a subcutaneous injection
Sponsors
Alvotech Swiss AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects diagnosed with active RA according to ACR/EULAR 2010 classification criteria * Subjects diagnosed with moderately to severe active RA as defined by ≥ 6 swollen (out of 66) and ≥6 tender (out of 68) joint counts, CRP \>1mg/l and with at least one of positive rheumatoid factor, positive anti-citrullinated peptide antibodies and/or evidence of 1 joint erosion of hands, wrist of dominant hand or feet at screening * Subjects must have taken methotrexate for ≥12 weeks
Exclusion criteria
* Prior treatment with biologics or Janus kinase inhibitors that may be used as disease-modifying anti-rheumatic drugs * Any past or concurrent medical conditions that could potentially increase the subject's risks or that would interfere with the study evaluation, procedures or study completion * Major chronic inflammatory disease or connective tissue disease other than RA or any active autoimmune disease * Presence of chronic obstructive pulmonary disease * Presence of chronic heart failure NYHA class III or IV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate comparative efficacy of AVT05 with EU-approved Simponi as measured by DAS28-CRP at week 16. | Week 16 | Change from baseline in DAS28-CRP response criteria at week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess additional efficacy measures of AVT05 and EU-Simponi in terms of DAS28-CRP | Weeks 4, 8, 12, 24, 32, 40, 48 and 52 | Change from baseline in DAS28-CRP response criteria at weeks 4, 8, 12, 24, 32, 40, 48 and 52 |
| Assess additional efficacy measures of AVT05 and EU-Simponi in terms of ACR20/50/70 and its individual components throughout the study | Weeks 4, 8, 12, 16, 24, 32, 40, 48 and 52 | Percentage of subjects achieving ACR20/50/70 at weeks 4, 8, 12, 16, 24, 32, 40, 48 and 52 |
Countries
Bulgaria
Outcome results
None listed