Clinical trials: Pharmacokinetics of Methotrexate
Rheumatoid Arthritis, DMARD-naive and Early Disease Patients
A Study of the EP4 Antagonist CR6086 in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis
CR6086 is a new, potent and selective, orally available, small molecule prostaglandin EP4 receptor antagonist, endowed with immunomodulatory properties.
- Trial name
- NCT03163966
- Testing
- CR6086, Methotrexate
- Where
- Czechia
- Volunteers
- 248 people
- Sponsor
- Rottapharm Biotech
Rheumatoid Arthritis
Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis
This study will evaluate the safety and tolerability of PF-04236921 administered monthly as three intravenous infusions. Each group of patients will be assigned to a dose level; Safety and tolerability of a low dose level will be…
- Trial name
- NCT00838565
- Testing
- dose level 1, dose level 2, dose level 3
- Where
- 8 sites in United States, South Korea and 1 more
- Volunteers
- 41 people
- Sponsor
- Pfizer
Osteosarcoma, Leukemia
Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze
The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.
- Conditions
- Osteosarcoma, Leukemia, Lymphoma
- Trial name
- LVPK (NCT00634504)
- Testing
- glucarpidase, high-dose methotrexate, leucovorin, high-dose methotrexate, leucovorin
- Where
- 25 sites in United States
- Volunteers
- 20 people
- Sponsor
- BTG International Inc.
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
SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis
The purpose of the study is to determine the efficacy, safety and pharmacokinetics of SC12267 (4SC-101, 35 mg) in combination with methotrexate in comparison to methotrexate alone in the treatment of patients suffering from…
- Trial name
- COMPONENT (NCT01010581)
- Testing
- SC12267 (4SC-101), Methotrexate, Folic Acid
- Where
- 27 sites in Bulgaria, Czechia and 2 more
- Volunteers
- 266 people
- Sponsor
- 4SC AG
Arthritis, Rheumatoid
Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis
CE 224,535 is being developed for the treatment of rheumatoid arthritis. The purpose of this study is to evaluate the safety and tolerability of CE 224,535 after 4 weeks of treatment in subjects with rheumatoid arthritis already…
- Trial name
- NCT00446784
- Testing
- CE-224,535, Methotrexate
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Pfizer
Rheumatoid Arthritis
A Study for Japanese Participants With Rheumatoid Arthritis (RA)
This study will evaluate the safety and tolerability of multiple doses of LY2127399 (tabalumab) in Japanese participants with RA. The study consists of a 20-week treatment period.
- Trial name
- NCT01253226
- Testing
- LY2127399 (Tabalumab)
- Where
- 10 sites in Japan
- Volunteers
- 32 people
- Sponsor
- Eli Lilly and Company
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
A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study in healthy volunteers, multiple dose study in patients with rheumatoid arthritis and multiple dose study in healthy volunteers.
- Trial name
- NCT01741493
- Testing
- ABT-494, Tofacitinib
- Where
- 5 sites in United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- AbbVie (prior sponsor, Abbott)
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Methotrexate
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Methotrexate
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of methotrexate.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Methotrexate, Pharmacokinetics of 7-hydroxymethotrexate, Healthy Subjects
- Trial name
- NCT01884636
- Testing
- isavuconazole, methotrexate
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Rheumatoid Arthritis
A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB2 compared to Remicade in subjects with moderate to severe Rheumatoid…
- Trial name
- NCT01936181
- Testing
- Remicade (infliximab), SB2 (proposed biosimilar to infliximab)
- Where
- 2 sites in Bulgaria, Lithuania
- Volunteers
- 584 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Lupus, Psoriatic Arthritis
A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients
The purpose of this study is to investigate effects of BMS-986165 on blood levels of methotrexate given as a single dose in healthy male patients.
- Trial name
- NCT03402087
- Testing
- Methotrexate, Leucovorin, BMS-986165
- Where
- Netherlands
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Rheumatoid Arthritis
A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB4 compared to Enbrel in subjects with moderate to severe Rheumatoid…
- Trial name
- NCT01895309
- Testing
- Enbrel (etanercept), SB4 (proposed biosimilar to etanercept)
- Where
- 2 sites in Poland, United Kingdom
- Volunteers
- 596 people
- Sponsor
- Samsung Bioepis Co., Ltd.
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
Arthritis, Rheumatoid, Healthy
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy
To evaluate the safety and tolerability of multiple doses of BI 655064 administered subcutaneously in healthy volunteers (HVs) and in rheumatoid arthritis (RA) patients.
- Trial name
- NCT01751776
- Testing
- BI 655064
- Where
- 25 sites in Czechia, Germany and 4 more
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Arthritis, Rheumatoid
Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis
The purpose of this study is to determine the safety and efficacy of ALD518 in three different doses in patients who have not had an adequate response to methotrexate.
- Trial name
- ALD518-003 (NCT00867516)
- Testing
- ALD518, Infusion without ALD518'
- Where
- 26 sites in Canada, Georgia and 4 more
- Volunteers
- 127 people
- Sponsor
- CSL Behring
Rheumatoid Arthritis
Study to Investigate the Effect of BMS-986142 on the Pharmacokinetics (PK) of Methotrexate and Probe Substrate Cocktail in Healthy Patients
To study the Pharmacokinetics (PK) parameters of montelukast, flurbiprofen, midazolam, digoxin, pravastatin, and MTX when coadministered with BMS-986142.
- Trial name
- NCT02456844
- Testing
- Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142, Methotrexate, Leucovorin and BMS-986142
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Rheumatoid Arthritis
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis
- Trial name
- NCT07171983
- Testing
- BMS-986454
- Where
- 9 sites in India
- Volunteers
- 46 people
- Sponsor
- Bristol-Myers Squibb
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
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