This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

HomeBrowseAboutFAQs
Log In
Sign Up
Rheumatoid Arthritis

Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX

Sponsored by Alvotech Swiss AG

About this trial

Last updated 9 months ago

Study ID

AVT05-GL-C01

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 9 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status