Clinical trials: Adalimumab
IBD
Combination Therapy With Two Biologicals
The efficacy and safety of dual biological therapy.
- Trial name
- Combi (NCT05135221)
- Testing
- dual biological therapy
- Where
- Finland
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Tampere University Hospital
Crohn's Disease, IBD
Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)
Crohn's disease and ulcerative colitis affect about 1.6 to 3 million people in the United States with many of those being young children and adolescents.
- Trial name
- ENvISION (NCT04131504)
- Testing
- Infliximab, Adalimumab
- Where
- 4 sites in United States
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Psoriasis, Atopic Dermatitis
Cardiovascular Risk Assessment in Patients With Severe Psoriasis Treated With Biologic Agents
Psoriasis is a common inflammatory disease of the skin and joints with a prevalence of 1-3% in the caucasian population of Northern Europe and the US.
- Conditions
- Psoriasis, Atopic Dermatitis, Atherosclerosis
- Trial name
- NCT01356758
- Testing
- biological treatment
- Where
- Denmark
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Psoriasis
MAP Study: Methotrexate and Adalimumab in Psoriasis
Assess the efficacy and safety of ADA compared to ADA/MTX in patient with Psoriasis. Compare Anti-ADA antibody formation and serum ADA levels in patients on ADA compared with those on combination ADA and MTX.
- Trial name
- MAP (NCT03217734)
- Testing
- Adalimumab, Methotrexate
- Where
- 4 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Jeffrey J Crowley MD
Pharmacokinetics, Safety
Study to Compare PK & Safety of Advixa With Humira in Healthy, Adult Subject Followed by Efficacy & Safety Study in RA Patients
Adalimumab is a recombinant monoclonal antibody (IgG1 subclass) against human TNF-α (Tumor Necrosis Factor-alpha). It is an immunosuppressive medication predominantly used to treat rheumatoid arthritis autoimmune disease.
- Conditions
- Pharmacokinetics, Safety, Efficacy, Rheumatoid Arthritis
- Trial name
- ACT (NCT05172817)
- Testing
- Advixa (Adalimumab)
- Where
- Bangladesh
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Institute for Developing Science and Health Initiatives, Bangladesh
Rheumatoid Arthritis
Investigation of Immunological and Pharmacological Factors for Response to Adalimumab in Rheumatoid Arthritis
Interventional study with minimal risks and constraints, prospective, mono-centric.
- Trial name
- PROMETHEE (NCT03110094)
- Testing
- Adalimumab, Healthy volunteers
- Where
- France
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Rennes University Hospital
Healthy
Comparative Clinical Trial to Evaluate Bioequivalency and Safety of Monoclonal Antibody Injection and Adalimumab in Chinese Healthy Volunteers
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety of human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection and Adalimumab when used…
- Trial name
- NCT02912247
- Testing
- human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection, adalimumab
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Healthy Subjects
Pharmacokinetics and Safety Study of LBAL in Healthy Subjects
To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®.
- Trial name
- NCT02206867
- Testing
- LBAL, Humira
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Bioequivalence, Phase 1
A Study Of CinnoRA (Adalimumab-CinnaGen) And Adalimumab (Humira) In Healthy Subjects
This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate CinnoRA® relative to adalimumab reference product (Humira®) and evaluate safety and tolerability of CinnoRA®, in a parallel fashion in healthy…
- Trial name
- NCT03273192
- Testing
- Adalimumab
- Where
- Iran
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Cinnagen
Psoriasis
Evaluation of IL 12B Genetic Polymorphism (rs3213094)
Psoriasis is a skin disorder that is chronic proliferative and inflammatory in nature. Extensor surfaces, scalp, and lumbosacral area are covered in erythematous plaques with silvery scales.
- Trial name
- NCT07128472
- Testing
- Humira
- Where
- Egypt
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- South Valley University
Healthy
Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)
This healthy volunteers study will evaluate 210 subjects who will receive a single sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European Union).
- Trial name
- NCT01870986
- Testing
- PF-06410293, Humira (adalimumab-EU), Humira (adalimumab-US)
- Where
- 2 sites in United States, Belgium
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Pfizer
Crohn's Disease, Ulcerative Colitis
The Effect of Infliximab on Sperm Quality
Background: The treatment of inflammatory bowel diseases (IBD) is based mainly on 3 compounds: 1- 5 aminosalysilates . 2- immunomodulators (Azathioprines). 3- Biologic therapies (Infliximab, Adalimumab) .
- Trial name
- NCT00745329
- Testing
- sperm quality test
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Tel-Aviv Sourasky Medical Center
Psoriasis
Adalimumab Biosimilar in Clinical Practice
This is an observational, retrospective, multicenter, and descriptive study of patients treated with adalimumab biosimilar for psoriasis, according to clinical practice.
- Trial name
- NCT04808739
- Testing
- Adalimumab
- Where
- Spain
- Volunteers
- 604 people, healthy volunteers welcome
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Inflammatory Bowel Disease
Ex-vivo Modulatory Effect of Biological Drugs for Inflammatory Bowel Disease on the Mucosa and on Peripheral Blood Mononuclear Cells
To characterize circulating DC subsets from healthy controls and IBD patients and to assess, following an ex vivo challenge, the effect of anti-TNF (infliximab, adalimumab and golimumab), anti-p40 -IL-12/IL-23- (ustekinumab) and…
- Trial name
- NCT03043677
- Testing
- Ex-vivo stimulation of cells with infliximab, golimumab, adalimumab, vedolizumab and ustekinumab
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Healthy Adult Male
A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects
The aim of this study is to establish comparability of pharmacokinetic parameters and similarity of the safety and immunogenicity profiles of single subcutaneous doses of BCD 057 100 mg/mL and BCD-057 50 mg/mL, as well as BCD-057…
- Trial name
- NCT07181694
- Testing
- Adalimumab (BCD-057) 100 mg/mL, Adalimumab (BCD-057) 50 mg/mL, Adalimumab (Humira) 100 mg/mL
- Where
- 4 sites in Russia
- Volunteers
- 444 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy
Assessment of Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects
This study will assess the pharmacokinetic (PK) and safety of a single 0.8 mL (40 mg) subcutaneous (SC) dose of M923 administered via an auto-injector (AI) or a prefilled syringe (PFS) in healthy subjects.
- Trial name
- NCT02675023
- Testing
- M923
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 603 people, healthy volunteers welcome
- Sponsor
- Momenta Pharmaceuticals, Inc.
Pharmacological Action
Pharmacogenomic in Colombian Patients With Rheumatoid Arthritis
The pharmacogenomics of the Colombian population with rheumatoid arthritis (RA), understood as the individual response to drugs depending on the genome of each patient, can be an explanation for the problems of effectiveness and…
- Trial name
- NCT03352622
- Testing
- CASES, CONTROLS
- Where
- Colombia
- Volunteers
- 372 people, healthy volunteers welcome
- Sponsor
- Universidad de Antioquia
Rheumatoid Arthritis
Th17 Responses Evaluated in RA Patients on Inhibitors of TNFα
Preliminary data suggest that up-regulation of Interleukin -17 (IL-17) and the T-helper 17 (Th17) pathway occurs in rheumatoid arthritis (RA) patients on anti-Tumour Necrosis Factor (TNF) therapy who demonstrated an incomplete…
- Trial name
- THERAPIST (NCT02620189)
- Testing
- Anti-TNF Biologics Therapy
- Where
- 8 sites in United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Queen Mary University of London
Healthy Volunteers
Pharmacokinetics, Safety and Tolerability Study of AVT02 to EU-approved and US-licensed Humira (Adalimumab)
This study has been designed as a multicentre, randomised, double-blind study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 compared to EU-Humira and US licenced Humira…
- Trial name
- NCT03849313
- Testing
- Adalimumab
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 390 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Crohn's Disease, Rheumatoid Arthritis
OTIS Humira Pregnancy Registry
The purpose of the OTIS Autoimmune disease in pregnancy study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live…
- Trial name
- NCT01086059
- Where
- United States
- Volunteers
- 944 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego