Clinical trials: Adalimumab
Healthy
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects
The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy subjects.
- Trial name
- NCT02144714
- Testing
- SB5, EU sourced Humira®, US sourced Humira®
- Where
- Germany
- Volunteers
- 189 people, healthy volunteers welcome
- Sponsor
- Samsung Bioepis Co., Ltd.
Ulcerative Colitis
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active…
- Trial name
- HIBISCUS I (NCT02163759)
- Testing
- Adalimumab, Etrolizumab
- Where
- 88 sites in United States, Argentina and 12 more
- Volunteers
- 358 people
- Sponsor
- Hoffmann-La Roche
Healthy Participants
Comparative Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of Adalimumab in Healthy Subjects
This is a randomized, double-blind, two-arm, parallel group, single-dose study to demonstrate pharmacokinetic, safety, tolerability and immunogenicity similarity of biosimilar candidate TUR01 to EU-sourced Humira® in healthy…
- Trial name
- NCT04439929
- Testing
- TUR01, Adalimumab-EU
- Where
- Germany
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Turgut İlaçları A.Ş.
Rheumatoid Arthritis
Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis
This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).
- Trial name
- OPTIMA (NCT00420927)
- Testing
- adalimumab, methotrexate
- Where
- 170 sites in United States, Argentina and 19 more
- Volunteers
- 1,032 people
- Sponsor
- Abbott
Hidradenitis Suppurativa
Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa
This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis…
- Trial name
- NCT05322473
- Testing
- Sonelokimab (M1095), Adalimumab
- Where
- 57 sites in United States, Bulgaria and 5 more
- Volunteers
- 234 people
- Sponsor
- MoonLake Immunotherapeutics AG
Rheumatoid Arthritis, Ankylosing Spondylitis
Greek Study on Work Productivity and Sleep in Patients With Rheumatic Diseases Treated With Adalimumab
Treatment with tumor necrosis factor (TNF) inhibitors, especially adalimumab, demonstrated an improvement in work productivity in participants with rheumatic diseases: rheumatoid arthritis (RA), psoriatic arthritis (PsA), and…
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- Trial name
- NCT01282372
- Volunteers
- 500 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Uveitis
Impact of Humira® Therapy on Ocular Inflammation, Selected Health Care Resource Utilization and Patient Reported Outcomes in Patients With Active Non-infectious Intermediate, Posterior and Panuveitis in Routine Clinical Practice
This study aims at evaluating real life effectiveness of originator adalimumab (Humira®) participants with active non-infectious intermediate, posterior and panuveitis (NIIPPU) despite high-dose corticosteroid therapy; including…
- Trial name
- HOPE (NCT03155243)
- Where
- 28 sites in Austria, Colombia and 10 more
- Volunteers
- 155 people
- Sponsor
- AbbVie
Moderate to Severe Rheumatoid Arthritis
MSB11022 in Moderate to Severe Rheumatoid Arthritis
The purpose of this study is to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult participants with rheumatoid arthritis (RA).
- Trial name
- Auriel-RA (NCT03052322)
- Testing
- MSB11022, EU-Humira
- Where
- 46 sites in Bulgaria, Czechia and 4 more
- Volunteers
- 288 people
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
Crohn's Disease
Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease
This study will evaluate the efficacy and safety of adalimumab induction and maintenance treatment in subjects with moderately to severely active Crohn's disease in China.
- Trial name
- NCT02499783
- Testing
- adalimumab
- Volunteers
- 205 people
- Sponsor
- AbbVie
Healthy Volunteers
Study to Determine the Pharmacokinetic (PK) Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Participants
The primary objective of this study is to determine the bioequivalence of ABP 501 (subcutaneous [SC] injection) compared to adalimumab (SC injection) as assessed principally by the area under the serum concentration-time curve…
- Trial name
- NCT05995691
- Testing
- ABP 501, Adalimumab
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Amgen
Crohn's Disease
Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine
The purpose of this study was intended to evaluate the long-term safety and effectiveness of adalimumab in participants with Crohn's disease (CD) who are treated as recommended in the product label.
- Trial name
- NCT01083680
- Volunteers
- 4,107 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Psoriasis
Adalimumab in Adult Japanese Subjects With Psoriasis
To evaluate efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with psoriasis
- Trial name
- NCT00647400
- Testing
- adalimumab
- Where
- 64 sites in Japan
- Volunteers
- 147 people
- Sponsor
- Abbott
Rheumatoid Arthritis, Ankylosing Spondylitis
Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab
The purpose of this study is to assess whether or not adalimumab (Humira®) can influence pain medication in participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) with or without…
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- Trial name
- NCT01273519
- Where
- 15 sites in Austria
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- AbbVie (prior sponsor, Abbott)
Psoriasis
Greek Study of the Quality of Life in Patients With Psoriasis Treated With Adalimumab
Primary objective To evaluate the quality of life of Adalimumab treated patients over a period of 12 months Secondary objectives To evaluate the long-term efficacy of Adalimumab in patients with moderate to severe chronic plaque…
- Trial name
- NCT01077128
- Where
- 61 sites in Greece
- Volunteers
- 500 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Ankylosing Spondylitis
Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis (AS) Patients
This was a prospective mono-country, multi-center study of the frequency of extra-axial manifestations (EAMs) in Ankylosing Spondylitis (AS) participants treated with adalimumab in routine clinical practice.
- Trial name
- AS PMOS (NCT02333383)
- Testing
- Adalimumab
- Volunteers
- 201 people
- Sponsor
- AbbVie
Hidradenitis Suppurativa (HS)
Observational Study Evaluating Long-Term Safety and Effectiveness of Humira in Patients With Hidradenitis Suppurativa
The objective of this study is to evaluate the long-term safety and effectiveness of Humira in patients with Hidradenitis Suppurativa (HS) in real-world clinical practice in Japan.
- Trial name
- NCT03894956
- Where
- 37 sites in Japan
- Volunteers
- 46 people
- Sponsor
- AbbVie
Crohn's Disease
Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a…
- Trial name
- NCT00105300
- Testing
- Adalimumab
- Where
- 56 sites in United States, Belgium and 2 more
- Volunteers
- 300 people
- Sponsor
- Abbott
Arthritis, Rheumatoid
Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects
This is a single site, parallel randomized, double blinded comparison of the safety, pharmacokinetics, and immunogenicity of a single 0.57 mg/kg dose of SYN060 to a single 0.57 mg/kg dose of adalimumab (Humira®) reference product…
- Trial name
- NCT03254810
- Testing
- SYN060, Adalimumab North American source, Adalimumab European source
- Where
- Australia
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Synermore Biologics Co., Ltd.
Ulcerative Colitis
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.
- Trial name
- NCT02632175
- Testing
- Adalimumab
- Where
- 16 sites in United States, Japan and 4 more
- Volunteers
- 59 people
- Sponsor
- AbbVie
Moderate to Severe Rheumatoid Arthritis
Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab
To evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis (RA) who did not respond to or lost a satisfactory response to adalimumab when used as their first biologic agent.
- Trial name
- ROCkIES (NCT01927757)
- Testing
- Etanercept, Methotrexate
- Where
- 45 sites in United States, Canada and 1 more
- Volunteers
- 90 people
- Sponsor
- Amgen