Auto-injector Real Life Handling in Patients

NCT04224194 | Completed Phase 3

• 1 other identifier: AVT02-GL-303
• Study Type: interventional
• Target: 107
• Locations: 2 countries
• Sites: 9

Brief Summary

To assess the real-life patient handling experience with the use of an autoinjector in patients with moderate to severe active Rheumatoid Arthritis (RA) who self-inject AVT02 subcutaneously (SC).

Conditions

RA

Keywords

auto injector pen in RA patients

Outcome Measures

Primary Outcomes (2)

• percentage of successful self-injections patient rated

  The percentage of successful self-injections as reported in the questionnaires completed by the patients (Patient Assessment Tool, Question 1), analyzing all self-injections occurring after the trained self-injection. The higher the % the better the result.

  up to the Week 8

• percentage of successful self-injections site staff rated

  The percentage of successful self-injections as reported in the questionnaires completed by the trial site personnel (Observer Assessment Tool, Question 1) , analyzing all self-injections occurring after the trained self-injection. The higher the % the better the result.

  up to the Week 8

Secondary Outcomes (1)

• frequency of any autoinjector handling events during the self-injection process

  Up to week 8

Study Arms (1)

Interventional, Single arm to evaluate autoinjector handling

OTHER

To assess the real-life patient handling experience with the use of an autoinjector in patients with moderate to severe active Rheumatoid Arthritis (RA) who selfinject AVT02 (adalimumab) subcutaneously (SC).

Combination Product: Adalimumab

Interventions

Adalimumab COMBINATION_PRODUCT

Combined product as Drug is delivered through an autoinjector pen on which real-life patient handling experience is assessed.

Interventional, Single arm to evaluate autoinjector handling

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is male or female, 18 to 80 years of age, inclusive, at time of Screening.
• Patients diagnosed with RA for at least 4 months and currently classified according to the 2010 American College of Rheumatology (ACR)/ European League Against Rheumatism classification criteria for RA (score ≥ 6/10).
• Patients with moderate to severe active RA as defined by ≥ 6 swollen (out of 66) and ≥ 6 tender (out of 68) joint counts and abnormal elevation of C-Reactive Protein (CRP) (≥ 6 mg/L) and fulfills one of the two criteria at screening: a) Positive rheumatoid factor b) Evidence of one joint erosion on radiological assessment of the hands, wrists, or feet at Screening.
• Disease Activity Score in 28 joints C-reactive protein (DAS28 CRP) score of ≥ 3.2 at Screening.
• Eligible to receive treatment on ambulatory care.
• RA functional Class I, II, or III.
• Patients must be taking methotrexate (MTX) orally for ≥ 12 weeks at a stable dose of ≥ 12.5 mg in the last 4 weeks prior to screening and plan to remain on stable dose throughout the study. Patients who are on methotrexate for a minimum of 10 mg per week will be eligible if there is documented intolerance to further dose escalation.
• If patients are using oral corticosteroids, they must have been on a stable dose of up to 10 mg/day prednisolone or equivalent, for ≥ 4 weeks prior to first study dose.
• Naive to adalimumab. Prior treatment with one biologic is allowed.
• Patient has a negative QuantiFERON test for tuberculosis (TB) during Screening.
• Note: Patients with a positive and indeterminate QuantiFERON test are allowed if they have all of the following:
• No evidence of active TB on chest radiograph within 3 months prior to the first dose of study drug.
• Documented history of adequate prophylaxis initiation prior to receiving study drug in accordance with local recommendations.
• No known exposure to active TB after most recent prophylaxis.
• Asymptomatic at Screening and baseline (BL).

You may not qualify if:

• Patients with previous experience of self-administering medications using an autoinjector or pen (either marketed or investigational).
• Patients who upon initial training are determined not to be acceptable candidates for self-administration.
• RA with significant secondary involvement of any systemic organ (including but not limited to vasculitis, pulmonary fibrosis).
• Prior treatment with more than 1 biologic or 1 protein kinase inhibitor DMARD for RA.
• Previous receipt of HUMIRA® (adalimumab) or a biosimilar of adalimumab.
• Prior treatment with TNF inhibitors for RA with lack of efficacy as per clinical judgment.
• Treatment with DMARD other than MTX within 4 weeks prior to screening (8 weeks in case of leflunomide and azathioprine).
• History of or current inflammatory joint disease other than RA (eg, gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (eg, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, or any overlap syndrome).
• Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement), within 8 weeks prior to informed consent or planned during the study, or history of infected joint prosthesis within 5 years.
• Pregnancy or breast feeding.
• Significant cardiac (eg, New York Heart Association ≥ III) or pulmonary disease (including obstructive pulmonary disease).
• Evidence of clinically significant uncontrolled concomitant disease (cardiac, renal, hepatic, pulmonary, metabolic, or gastro-intestinal) which in the Investigator's or medical monitor's opinion would preclude patient participation.
• Primary or secondary immunodeficiency (history of or currently active), including known history of human immunodeficiency virus (HIV) infection.
• Patient has an active and serious infection or history of infections as follows:
• Any active infection:

Sponsors & Collaborators

• Alvotech Swiss AG: lead

Study Sites (9)

Aleksandre Aladashvili Clinic LLC

Tbilisi, 0102, Georgia

Location

"National Institute of Endocrinology" LTD

Tbilisi, 0159, Georgia

Location

JSC "EVEX Hospitals"

Tbilisi, 0159, Georgia

Location

Tbilisi Heart and Vascular Clinic LTD

Tbilisi, 0159, Georgia

Location

Georgian Dutch Hospital LLC

Tbilisi, 0167, Georgia

Location

Communal Noncommercial Enterprise "City Clinical Hospital 8" of Kharkiv City Council

Kharkiv, 61176, Ukraine

Location

SI D. F. Chebotarev Institute of Gerontology NAMS Ukraine

Kyiv, 04114, Ukraine

Location

Municipal Institution "Zaporozhye City Clinical hospital No.10"

Zaporizhzhya, 69001, Ukraine

Location

CU "Zaporizhzhia Regional Clinical Hospital" ZRC

Zaporizhzhya, 69600, Ukraine

Location

Related Publications (1)

• Damjanov N, Kirvalidze N, Kurashvili N, Berti F, Steiger M, Sobierska J, Guenzi E, Otto H, Sattar A, Haliduola HN, Edwald E, Stroissnig H. Assessment of real-life patient handling experience of AVT02 administered subcutaneously via autoinjector in patients with moderate to severe active rheumatoid arthritis: an open-label, single-arm clinical trial, then an extension phase of AVT02 administered with a prefilled syringe. Expert Opin Biol Ther. 2023 Jul-Dec;23(8):781-789. doi: 10.1080/14712598.2022.2131392. Epub 2022 Oct 26.

  PMID: 36205514 DERIVED

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Nemanja Damjanov, Prof

  University School of Medicine, Dir. Inst. of Rheumatology, Belgrade

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: January 13, 2020
• Study Start: November 4, 2019
• Primary Completion: July 8, 2020
• Study Completion: February 26, 2021
• Last Updated: May 5, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

UA (4); GE (5)