Clinical trials: Inadequate Response
Rheumatoid Arthritis
An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) Therapy
This study was an extension to study MA21573 [NCT00750880], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological…
- Trial name
- NCT00883753
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- 171 sites in Australia, Canada and 12 more
- Volunteers
- 934 people
- Sponsor
- Hoffmann-La Roche
Primary Immune Thrombocytopenia (ITP)
A Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary ITP Who Failed Corticosteroids.
The purpose of this study is to assess the efficacy, safety and pharmacokinetics (PK) of ianalumab (VAY736) in addition to eltrombopag treatment; and to inform the dose of ianalumab in pediatric patients (5 to <18 years of age)…
- Trial name
- VAYHIT-P (NCT07660172)
- Testing
- Ianalumab, Eltrombopag
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to < 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by…
- Trial name
- NCT05677451
- Testing
- LOU064 (blinded)
- Where
- 49 sites in United States, Argentina and 15 more
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
Primary Biliary Cirrhosis
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or…
- Trial name
- NCT02955602
- Testing
- MBX-8025 2 mg Capsule, MBX-8025 5 mg Capsule, MBX-8025 10 mg Capsule
- Where
- 38 sites in United States, Canada and 2 more
- Volunteers
- 119 people
- Sponsor
- Gilead Sciences
Psoriatic Arthritis
Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy
The primary objective of this study is to evaluate the effect of filgotinib compared to placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response in participants with active psoriatic arthritis…
- Trial name
- PENGUIN 2 (NCT04115839)
- Testing
- Filgotinib
- Where
- 59 sites in United States, Australia and 9 more
- Volunteers
- 106 people
- Sponsor
- Gilead Sciences
Rheumatoid Arthritis
A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)
This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally.
- Trial name
- NCT00422383
- Testing
- rituximab [MabThera/Rituxan]
- Where
- 91 sites in Australia, Belgium and 16 more
- Volunteers
- 378 people
- Sponsor
- Hoffmann-La Roche
Primary Biliary Cirrhosis
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver…
- Trial name
- ELATIVE (NCT04526665)
- Testing
- Elafibranor 80mg
- Where
- 115 sites in United States, Argentina and 12 more
- Volunteers
- 161 people
- Sponsor
- Ipsen
Arthritis, Rheumatoid
Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)
This study [contRAst 2 (201791: NCT03970837)] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with…
- Trial name
- contRAst 2 (NCT03970837)
- Testing
- GSK3196165 (Otilimab), Tofacitinib
- Where
- 269 sites in United States, Argentina and 16 more
- Volunteers
- 1,764 people
- Sponsor
- GlaxoSmithKline
Rheumatoid Arthritis
A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate
This 3 arm study assessed the efficacy of rituximab (MabThera®/Rituxan®) in the prevention of progression of structural joint damage in participants with active rheumatoid arthritis who had an inadequate clinical response to…
- Trial name
- SCORE (NCT00578305)
- Testing
- Rituximab, Methylprednisolone, Methotrexate
- Where
- 60 sites in Argentina, Brazil and 17 more
- Volunteers
- 185 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis (RA)
A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)
The study objectives of Period 1 of this study were to compare the efficacy, safety, and tolerability of upadacitinib versus placebo for the treatment of signs and symptoms of subjects from China and selected countries including…
- Trial name
- NCT02955212
- Testing
- Upadacitinib
- Where
- 43 sites in Brazil, China and 1 more
- Volunteers
- 338 people
- Sponsor
- AbbVie
Generalized Anxiety Disorder
A Study To Assess Adverse Events and Change in Disease Activity With Oral Cariprazine When Added to Antidepressant Therapies (ADTs) Compared to Placebo in Adult Participants With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response to ADTs Alone
Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD.
- Trial name
- CAR aGAD Ph 2 (NCT04965272)
- Testing
- Cariprazine 0.75 mg/day, Cariprazine 1.5 mg/day, Cariprazine 3.0 mg/day
- Where
- 36 sites in United States
- Sponsor
- AbbVie
Major Depressive Disorder
Study With Vortioxetine on Emotional Functioning in Patients With Depression
The study will evaluate effectiveness of flexible dose vortioxetine 10-20 mg/day on emotional functioning in patients with MDD with an inadequate response to SSRIs/SNRIs.
- Trial name
- COMPLETE (NCT03835715)
- Testing
- Vortioxetine
- Where
- 23 sites in France, Italy and 2 more
- Volunteers
- 150 people
- Sponsor
- H. Lundbeck A/S
Primary Biliary Cholangitis
Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.
- Trial name
- NCT06247735
- Testing
- K-808 (Dose A), K-808 (Dose B)
- Where
- 38 sites in United States, Canada and 1 more
- Volunteers
- 46 people
- Sponsor
- Kowa Research Institute, Inc.
Rheumatoid Arthritis
A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).
The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.
- Trial name
- NCT02222493
- Testing
- PF-06438179, Infliximab
- Where
- 184 sites in United States, Australia and 26 more
- Volunteers
- 650 people
- Sponsor
- Pfizer
Rheumatoid Arthritis
Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents (CAIN457F2309 and CAIN457F2309E1)
The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α…
- Trial name
- NURTURE 1 (NCT01350804)
- Testing
- AIN457, Abatacept
- Where
- 117 sites in United States, Brazil and 13 more
- Volunteers
- 551 people
- Sponsor
- Novartis Pharmaceuticals
Psoriasis
A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to…
- Trial name
- NAVIGATE (NCT02203032)
- Testing
- Ustekinumab, Guselkumab
- Where
- 85 sites in United States, Australia and 8 more
- Volunteers
- 872 people
- Sponsor
- Janssen Research & Development, LLC
Rheumatoid Arthritis
Prospective, Multi-Center, Observational, Whole Blood Specimen Collection Study in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to a DMARD Starting a New bDMARD or tsDMARD Treatment +/- csDMARD
The primary goal of this study is to assess a cfDNA-based blood test using genetic, transcriptomic and/or epigenetic information to help doctors predict the best treatment options for rheumatoid arthritis (RA) patients with…
- Trial name
- NCT05936970
- Where
- 42 sites in United States
- Volunteers
- 1,410 people
- Sponsor
- Aqtual, Inc.
Hypercholesterolemia
A Post-Marketing Clinical Trial of Pemafibrate in Patients ｗith Hypercholesterolemia and Inadequate Response to Statins
To investigate the efficacy and safety of Pemafibrate 0.2 mg/day or 0.4 mg/day for 12 weeks in patients with hypercholesterolemia and inadequate response to statins, using placebo as a control.
- Trial name
- NCT07634484
- Testing
- Pemafibrate 0.2 mg/day, Pemafibrate 0.4 mg/day
- Where
- 10 sites in Japan
- Volunteers
- 120 people
- Sponsor
- Kowa Company, Ltd.
Rheumatoid Arthritis
Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment
The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American…
- Trial name
- FINCH 2 (NCT02873936)
- Testing
- Filgotinib, csDMARDs
- Where
- 104 sites in United States, Argentina and 13 more
- Volunteers
- 449 people
- Sponsor
- Gilead Sciences
Rheumatoid Arthritis
Comparative Study of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
This is a Phase 3, multicenter, multinational, randomized, double-blind, parallel-group, active-control study to compare efficacy, safety, immunogenicity, and PK of BAT1806 compared with RoActemra in subjects with RA that is…
- Trial name
- NCT03830203
- Testing
- BAT1806, Actemra(EU-licensed)
- Where
- China
- Volunteers
- 621 people
- Sponsor
- Bio-Thera Solutions