Clinical trials: Pharmacokinetics of Methotrexate
Rheumatic Diseases
Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate
This study is to assess standardized Adalimumab (ADA) concentrations in Pediatric inflammatory rheumatic diseases (PiRD) patients treated with ADA for ≥ 12 weeks with and without concomitant methotrexate (MTX) therapy and to…
- Trial name
- ADA in PiRD (NCT04042792)
- Testing
- pharmacokinetics (PK) measurement
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 28 people
- Sponsor
- University Hospital, Basel, Switzerland
Juvenile Idiopathic Arthritis
Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan
The purpose of this study is to assess the efficacy of Abatacept after intravenous administration in Japanese children and adolescents with active juvenile idiopathic arthritis who have a history of an inadequate response or…
- Trial name
- NCT01835470
- Testing
- Abatacept
- Where
- 13 sites in Japan
- Volunteers
- 23 people
- Sponsor
- Bristol-Myers Squibb
Central Nervous System Lymphoma, Intraocular Lymphoma
A Safety Study of Rituximab Plus MTX Injected Into the Cerebrospinal Fluid in the Treatment of Brain Lymphoma
Rituximab is the first monoclonal antibody to receive approval in the treatment of cancer and has been proven to lead to extended survival when administered intravenously in the treatment of patients with systemic non-Hodgkin's…
- Trial name
- NCT00221325
- Testing
- Intraventricular Rituximab Plus MTX
- Where
- 4 sites in United States
- Volunteers
- 14 people
- Sponsor
- University of California, San Francisco
Lymphoma
Study of AMG 531 to Evaluate the Safety & Efficacy in Patients With Non-Hodgkin's Lymphoma
The goal of this clinical research study is to find the highest safe dose of AMG 531 that can be given to treat thrombocytopenia (low platelet counts) in patients who have received chemotherapy.
- Trial name
- NCT00299182
- Testing
- AMG 531, Rituximab, Cyclophosphamide
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- M.D. Anderson Cancer Center
Gout
A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.
To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the…
- Trial name
- NCT06298071
- Testing
- SIBP-R002, Methotrexate
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Shanghai Institute Of Biological Products
Rheumatoid Arthritis
A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis
This study is being carried out to investigate if AZD5672 is effective in treating Rheumatoid Arthritis (RA) and if so how it compares to placebo (a substance which does not have any action) and etanercept (a medicine already…
- Trial name
- ESCAPE (NCT00713544)
- Testing
- AZD5672, Etanercept
- Where
- 49 sites in Bulgaria, Colombia and 12 more
- Volunteers
- 373 people
- Sponsor
- AstraZeneca
Healthy
GLPG0259 Multiple Ascending Dose and Methotrexate Drug-drug Interaction (DDI) in Healthy Subjects
The purpose of the study is to evaluate the safety and tolerability of multiple increasing oral doses of GLPG0259 compared to placebo.
- Trial name
- NCT00989703
- Testing
- GLPG0259, Methotrexate
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Rheumatoid Arthritis
A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
This is a randomised, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to Humira® in subjects with moderate to severe RA…
- Trial name
- NCT02167139
- Testing
- Humira (adalimumab), SB5 (proposed biosimilar to adalimumab)
- Where
- 2 sites in Lithuania, Poland
- Volunteers
- 544 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Rheumatoid Arthritis
Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid Arthritis
This Phase 2a study is designed to evaluate the safety and tolerability of multiple subcutaneous (SC) doses of BG9924, administered in a cohort dose-escalation fashion, in patients with active rheumatoid arthritis (RA) who have…
- Trial name
- NCT00292422
- Testing
- BG9924
- Where
- 10 sites in United States, Poland
- Volunteers
- 50 people
- Sponsor
- Biogen
Rheumatoid Arthritis
A Study in Rheumatoid Arthritis
The purpose of this study is to evaluate the safety and tolerability of multiple doses of LY2439821 in Japanese patients with rheumatoid arthritis.
- Trial name
- NCT01253265
- Testing
- LY2439821
- Where
- 8 sites in Japan
- Volunteers
- 32 people
- Sponsor
- Eli Lilly and Company
Rheumatoid Arthritis
Co-Administration Of Methotrexate And CP-690,550
This study was designed to estimate the effects of methotrexate (MTX) on the pharmacokinetics (PK) of CP-690,550 when administered to subjects with rheumatoid arthritis (RA), to estimate the effects of CP-690,550 on the PK of MTX…
- Trial name
- NCT01745055
- Testing
- CP-690,550 (tofacitinib), Methotrexate (MTX)
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- Pfizer
Rheumatoid Arthritis
ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Participants With Moderate to Severe Active Rheumatoid Arthritis (RA)
This study evaluates ATI-450 plus MTX versus placebo plus MTX in participants with moderate to severe active RA who have had an inadequate response to MTX alone.
- Trial name
- NCT05279417
- Testing
- ATI-450 50 mg oral tablet BID, Methotrexate, ATI-450 20 mg oral tablet BID
- Where
- 50 sites in United States, Bulgaria and 2 more
- Volunteers
- 251 people
- Sponsor
- Aclaris Therapeutics, Inc.
Rheumatoid Arthritis
A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients
The main aim of this clinical study is to investigate whether the blood concentration of methotrexate changes when AZD9056 is co- administered together with methotrexate.
- Trial name
- NCT00920608
- Testing
- AZD9056, Methotrexate
- Volunteers
- 12 people
- Sponsor
- AstraZeneca
Rheumatoid Arthritis
A Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis
The primary purpose of the study is to evaluate the effect of ASP1707 twice daily on the pharmacokinetics of once weekly oral methotrexate (MTX).
- Trial name
- NCT02867306
- Testing
- ASP1707, methotrexate (MTX)
- Where
- Moldova
- Volunteers
- 10 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Rheumatoid Arthritis
A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)
In this study, patients with moderate to severe rheumatoid arthritis who are being treated with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan (Rituximab) or MabThera (Rituximab).
- Trial name
- REFLECTIONS (NCT01526057)
- Testing
- PF-05280586, MabThera, Rituxan
- Where
- 84 sites in United States, Australia and 8 more
- Volunteers
- 220 people
- Sponsor
- Pfizer
Rheumatoid Arthritis (RA)
Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114
To compare the efficacy of SMP-114 (120 and 240 mg/d) versus placebo in terms of the percentage of patients meeting the American College of Rheumatology criteria for 20% improvement in RA (ACR20) at week 24.
- Trial name
- NCT00296257
- Testing
- SMP-114
- Where
- 46 sites in Czechia, Germany and 4 more
- Volunteers
- 312 people
- Sponsor
- Dainippon Sumitomo Pharma Europe LTd.
Central Nervous System Neoplasms, Lymphoma, Large B-Cell, Diffuse
Coproporphyrine Isomers and Methotrexate Elimination
High dose methotrexate (MTX) is responsible of severe toxicity in patients in whom elimination from plasma is delayed. Factors responsible for MTX accumulation are partly known but some patients still experience toxicity despite…
- Conditions
- Central Nervous System Neoplasms, Lymphoma, Large B-Cell, Diffuse, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma
- Trial name
- COMETH (NCT00822432)
- Where
- 2 sites in France
- Volunteers
- 85 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Rheumatoid Arthritis
Phase 1b Study of PLX5622 in Rheumatoid Arthritis Patients Who Are Receiving Methotrexate
PLX115-02 is a phase 1b study to assess how the study drug, PLX5622: 1. affects the body, 2. how the body affects PLX5622 3. the interaction of PLX5622 with Methotrexate and 4.
- Trial name
- NCT01329991
- Testing
- PLX5622
- Where
- 4 sites in United States
- Volunteers
- 26 people
- Sponsor
- Plexxikon
Arthritis, Rheumatoid
A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients
The purpose of the study is to compare the long-term safety, effectiveness and immunogenicity of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have completed study FKB327-002 and have inadequate disease…
- Trial name
- ARABESC-OLE (NCT02405780)
- Testing
- FKB327, Humira®
- Where
- 92 sites in United States, Canada and 9 more
- Volunteers
- 645 people
- Sponsor
- Fujifilm Kyowa Kirin Biologics Co., Ltd.
Rheumatoid Arthritis
Study Evaluating Multiple Ascending Doses Of ATN-103 In Japanese Subjects With Rheumatoid Arthritis
This primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic properties of multiple ascending doses of ATN-103 administered subcutaneously (below the skin) to Japanese subjects with active…
- Trial name
- NCT01007175
- Testing
- ATN-103 10 mg q4wks, ATN-103 30 mg q4wks, ATN-103 80 mg q4wks
- Where
- 15 sites in Japan
- Volunteers
- 60 people
- Sponsor
- Ablynx, a Sanofi company