Clinical trials: Pharmacokinetics of Methotrexate
Rheumatoid Arthritis
Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)
The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in…
- Trial name
- NCT00791921
- Testing
- CDP870
- Where
- 7 sites in Japan
- Volunteers
- 230 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Rheumatoid Arthritis
Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis
The purpose of the study is to evaluate the effect of LX3305 on methotrexate (MTX) pharmacokinetics and to evaluate the safety and tolerability of LX3305 given over 14 days in subjects with stable rheumatoid arthritis that are…
- Trial name
- NCT00847886
- Testing
- LX3305, Methotrexate
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Lexicon Pharmaceuticals
Rheumatoid Arthritis
Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate
This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients with active RA receiving…
- Trial name
- NCT00369928
- Testing
- PG-760564
- Where
- 53 sites in United States, Czechia and 4 more
- Volunteers
- 254 people
- Sponsor
- Procter and Gamble
Rheumatoid Arthritis
Efficacy, Pharmacokinetics, Safety, and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japanese Patients
The purpose of this study is to assess the efficacy, pharmacokinetics, safety, and immunogenicity of abatacept after subcutaneous and intravenous administration in Japanese participants with active rheumatoid arthritis and…
- Trial name
- NCT01001832
- Testing
- Intravenous (IV) abatacept, Subcutaneous (SC) abatacept
- Where
- 33 sites in Japan
- Volunteers
- 118 people
- Sponsor
- Bristol-Myers Squibb
Rheumatoid Arthritis
A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate
The primary objective of this study was to evaluate the effect of GLPG3970 compared to placebo on the signs and symptoms of Rheumatoid Arthritis (RA) in participants with moderately to severely active RA and an inadequate…
- Trial name
- LADYBUG (NCT04577781)
- Testing
- GLPG3970
- Where
- 9 sites in Bulgaria, Georgia and 2 more
- Volunteers
- 28 people
- Sponsor
- Lakefront Biotherapeutics NV
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
Arthritis, Juvenile
A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy
The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of golimumab administered intravenously (IV) to pediatric participants with…
- Trial name
- GO-VIVA (NCT02277444)
- Testing
- Golimumab, Methotrexate
- Where
- 38 sites in United States, Argentina and 7 more
- Volunteers
- 130 people
- Sponsor
- Janssen Research & Development, LLC
Uncontrolled Gout, Chronic Gout
A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)
This trial is to assess efficacy, safety, blood levels and bodily effects of up to 2 dose levels of intravenous (IV) pegloticase (KRYSTEXXA) infusions at every 4 week intervals (Q4 Weeks) for up to 6 months (Day 1 to 24 weeks…
- Trial name
- FORWARD OL (NCT04762498)
- Testing
- Pegloticase, Methotrexate (MTX)
- Where
- 12 sites in United States
- Volunteers
- 54 people
- Sponsor
- Amgen
Rheumatoid Arthritis
Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis
The purpose of this study is to determine whether the study drug, BMS-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and…
- Trial name
- NCT02638948
- Testing
- BMS-986142, Methotrexate
- Where
- 104 sites in United States, Argentina and 15 more
- Volunteers
- 508 people
- Sponsor
- Bristol-Myers Squibb
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.
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
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
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
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 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.
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