Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX
NCT ID: NCT05842213
Last Updated: 2024-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
502 participants
INTERVENTIONAL
2023-03-30
2024-09-24
Brief Summary
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The study will consist of up to 4-week Screening Period, a 48-week Treatment Period, and a 4-week Safety Follow-up Period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AVT05
AVT05 is the proposed biosimilar to Simponi. Subjects in this arm will receive AVT05 50mg s.c. every 4 weeks until week 48.
Intervention: Biological: Golimumab
AVT05 (proposed biosimilar to golimumab)
AVT05 is a recombinant human IgG1қ mAb developed as a subcutaneous injection
Simponi
Subjects in this arm will receive EU Simponi 50mg s.c. every 4 weeks until week 12. At week 16 responders will be re-randomized in a 1:1 ratio to receive either:
AVT05 50mg s.c. every 4 weeks until week 48 Simponi 50mg s.c. every 4 weeks until week 48 Intervention: Biological: Golimumab
AVT05 (proposed biosimilar to golimumab)
AVT05 is a recombinant human IgG1қ mAb developed as a subcutaneous injection
Simponi (Golimumab)
Simponi (Golimumab) is a recombinant human IgG1қ mAb developed as a subcutaneous injection
Interventions
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AVT05 (proposed biosimilar to golimumab)
AVT05 is a recombinant human IgG1қ mAb developed as a subcutaneous injection
Simponi (Golimumab)
Simponi (Golimumab) is a recombinant human IgG1қ mAb developed as a subcutaneous injection
Eligibility Criteria
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Inclusion 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Alvotech Swiss AG
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Bucknall
Role: STUDY_DIRECTOR
Alvotech Swiss AG
Locations
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Rheumatology clinic, University Multiprofile Hospital for Active Treatment Kaspela
Plovdiv, , Bulgaria
Countries
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Other Identifiers
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AVT05-GL-C01
Identifier Type: -
Identifier Source: org_study_id
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