NCT05842213CompletedPhase 3
Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX
Randomized, Double-blind, 2-arm Multicenter Study to Investigate the Efficacy, Safety and Immunogenicity Between Subcutaneous AVT05 and EU-approved Simponi® in Subjects with Moderate to Severe Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 2 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 502 (actual)
- First submitted
- 24 Apr 2023
- Start date
- 30 Mar 2023
- Primary completion date
- 4 Mar 2024
- Lead sponsor
- Alvotech Swiss AG
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05842213
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 502
- From 30 Mar 2023 to the primary completion date, 4 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rheumatology clinic, University Multiprofile Hospital for Active Treatment Kaspela Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.