Clinical trials: Adalimumab
Healthy
Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects
This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to establish pharmacokinetic equivalence of BI 695501 to adalimumab.
- Trial name
- NCT01505491
- Testing
- adalimumab, BI695501
- Where
- 2 sites in New Zealand
- Volunteers
- 193 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
Adalimumab PK Bioequivalence Study to EU and US Sourced Humira
Double-Blind, 3-Way Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of BMO-2 to EU and US Sourced Humira® Administered as a Single Dose (40 mg) Subcutaneous Injection in Healthy Adults.
- Trial name
- NCT02472912
- Testing
- BMO-2, EU-Humira, US-Humira
- Where
- Belgium
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Mylan Inc.
Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis
Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS
The primary objective of this study is to demonstrate equivalence of the pharmacokinetic (PK) profile of MSB11022 administered by either an auto-injector (AI) or a pre-filled syringe (PFS) as single subcutaneous (s.c.) injection…
- Conditions
- Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
- Trial name
- NCT04018599
- Testing
- 40 mg MSB11022
- Where
- 2 sites in United States
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
Psoriasis, Psoriatic Arthritis
IKBKB Gene Polymorphism (Single Nucleotide Polymorphism) (SNP) in Psoriatic and Psoriatic Arthritis Patients
Psoriasis is a chronic inflammatory skin disease characterized by scaly indurated erythema. It impairs patients' quality of life enormously. Psoriasis refers to a persistent inflammatory illness of the skin and joints.
- Trial name
- NCT06729463
- Testing
- Humira
- Where
- Egypt
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- South Valley University
Perianal Fistula, Crohn Disease
Surgical Closure vs Anti-TNF in the Treatment of Perianal Fistulas in Crohn's Disease (PISA-II): a Comprehensive Cohort Design
Currently, the treatment of Crohn's patients with perianal fistulas predominantly exists of anti-TNF medication. However, its efficiency has never been directly compared to surgical closure of the perianal fistula.
- Trial name
- PISA-II (NCT06441526)
- Testing
- anti-tumour necrosis factor α antibodies, Advancement plasty
- Where
- Netherlands
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Adalimumab
A Study Comparing the Pharmacokinetics (PK) of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 ml (ABP 501-LCF) in Healthy Adult Participants
To determine the pharmacokinetic (PK) comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) compared to ABP 501 40 mg/0.8 mL (ABP 501-LCF) following single-dose subcutaneous (SC) injection, as assessed principally by area under the…
- Trial name
- NCT05909852
- Testing
- ABP 501-HCF, ABP 501-LCF
- Where
- 3 sites in United States
- Volunteers
- 372 people, healthy volunteers welcome
- Sponsor
- Amgen
Ulcerative Colitis, Thromboembolism
Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events
Post-authorization, prospective and unicenter clinical trial, in which patients with UC will be included. The treatment with anti-TNFα (infliximab, adalimumab or golimumab) or JAK-inhibitors (tofacitinib) will be initiated by…
- Trial name
- NCT05313620
- Testing
- Tofacitinib, Infliximab Adalimumab y Golimumab
- Where
- Spain
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Pain, Injection Site
Adalimumab Microneedles in Healthy Volunteers
Adalimumab (Humira, AbbVie) is a highly effective treatment for a variety of auto-immune/auto-inflammatory diseases including juvenile idiopathic arthritis (JIA).
- Trial name
- NCT03607903
- Testing
- Adalimumab ID, Adalimumab SC, Saline ID
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Centre for Human Drug Research, Netherlands
Inflammatory Bowel Disease (IBD)
Cross Sectional Study of Vaccine Antibody Response in Inflammatory Bowel Disease Patients
The investigators proposed study is the first of its kind. The investigators will measure measles, mumps, rubella, tetanus, diphtheria and pertussis antibodies in patients on the current IBD treatment modalities and compare the…
- Trial name
- NCT02434133
- Testing
- Blood Draw/Data Collection
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Crohn Disease
Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
Crohn's disease (CD) is a chronic inflammatory bowel disease. CD pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota in predisposed hosts.
- Trial name
- MIRACLE (NCT04997733)
- Testing
- Fecal Microbiota Transplantation (FMT)
- Where
- France
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Chronic Granulomatous Disease, Crohn'S-like IBD
Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease
This study will determine if the drug infliximab is safe for treating inflammatory bowel disease (IBD) in patients with chronic granulomatous disease (CGD).
- Conditions
- Chronic Granulomatous Disease, Crohn'S-like IBD, Inflammatory Bowel Disease (IBD)
- Trial name
- NCT00325078
- Testing
- Infliximab
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Subjects
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))
This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to…
- Trial name
- B538-07 (NCT02237729)
- Testing
- PF-06410293, Adalimumab-US, Adalimumab-EU
- Where
- 8 sites in United States
- Volunteers
- 362 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Subjects
A Study to Investigate How Well an Intracolonic Formulation of Two Monoclonal Antibodies is Tolerated in Healthy Participants and the Ability for the Antibodies to be Taken up by the Body Via the Colon
This is a proof-of-concept study to investigate whether antibodies (guselkumab and adalimumab) delivered directly to the colon can enter the systemic circulation.
- Trial name
- NCT07788807
- Testing
- Adalimumab, Guselkumab, SDL-001
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Surmount Services, Inc.
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.
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
Ulcerative Colitis
Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
The primary goal of the study is to develop an early (within 4 weeks) combined microbiota/metabolic signature predicting clinical response upon anti-inflammatory treatment in UC patients.
- Trial name
- COMMIT (NCT05702879)
- Testing
- Ozanimod, TNF Inhibitor, Steroids
- Where
- Switzerland
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Healthy
Pharmacokinetics and Safety in Healthy Volunteers
Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish pharmacokinetic similarity of BI 695501 to adalimumab.
- Trial name
- NCT02045979
- Testing
- BI 695501, adalimumab-EU source, adalimumab-US source
- Where
- 3 sites in Belgium, New Zealand
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Pharmacokinetics and Safety in Healthy Volunteers
Investigate the pharmacokinetics, safety and tolerability of SCT630 and to establish pharmacokinetic similarity of SCT630 to adalimumab.
- Trial name
- NCT03917628
- Testing
- SCT630, adalimumab-EU source
- Where
- China
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Sinocelltech Ltd.
Healthy Subjects
A Study of PF-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects
This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC) injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects
- Trial name
- B538-05 (NCT02572245)
- Testing
- PF-06410293 PFS, PF-06410293 PFP
- Where
- United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Pfizer
Uveitis
An Interventional Study of Upadacitinib Extended-Release Tablets in Patients With Refractory Uveitis
Upadacitinib sustained-release tablets have not yet been approved for the treatment of uveitis. The current use falls under the category of "off-label medication", which means providing patients with potentially beneficial…
- Trial name
- NCT07773623
- Testing
- Upadacitinib Extended-Release Tablets
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tianjin Medical University