Clinical trials: Inadequate Response
Ulcerative Colitis, Active Moderate
Adacolumn in Refractory UC Patients Trial
The objectives of the study are to observe and document the efficacy and safety of 5 or more Adacolumn treatments, administered once weekly over 5 or more weeks, in a specific subset of ulcerative colitis patients.
- Trial name
- ART (NCT01481142)
- Testing
- (GMA) Adsorptive Apheresis
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Otsuka Pharmaceutical Europe Ltd
Primary Immune Thrombocytopenia
A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with…
- Trial name
- VAYHIT2 (NCT05653219)
- Testing
- Ianalumab, Eltrombopag
- Where
- 74 sites in United States, Argentina and 22 more
- Volunteers
- 152 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis
A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)
This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who had failed a three month therapeutic…
- Trial name
- AUGUST I (NCT00430495)
- Testing
- Atacicept
- Where
- 2 sites in United States, Canada
- Volunteers
- 256 people
- Sponsor
- EMD Serono
Paroxysmal Nocturnal Hemoglobinuria (PNH)
BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants With Inadequate Response to C5 Inhibitor Therapy
The purpose of this study was to determine the efficacy and safety of BCX9930 monotherapy for the treatment of PNH compared to continued C5 inhibitor therapy in adult PNH participants with residual anemia despite treatment with a…
- Trial name
- REDEEM-1 (NCT05116774)
- Testing
- Eculizumab, Ravulizumab, BCX9930
- Where
- 7 sites in France, Hungary and 3 more
- Volunteers
- 12 people
- Sponsor
- BioCryst Pharmaceuticals
Major Depressive Disorder
The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone
The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to…
- Trial name
- NCT03739203
- Testing
- Cariprazine, Antidepressant Therapy (ADT)
- Where
- 112 sites in United States, Canada and 6 more
- Volunteers
- 752 people
- Sponsor
- AbbVie
Rheumatoid Arthritis
A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent
This open-label study will evaluate the efficacy and safety of tocilizumab as monotherapy or in combination with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) in participants with active…
- Trial name
- ACT-MOVE (NCT02046603)
- Testing
- Tocilizumab, DMARDs, Oral Corticosteroids
- Where
- 38 sites in United Kingdom
- Volunteers
- 162 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.
This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with active rheumatoid arthritis who currently…
- Trial name
- NCT00773461
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- 9 sites in China
- Volunteers
- 209 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis
This Phase IIa study aims at investigating the safety and tolerability of 2 dose-levels of ABX464 administered daily in combination with methotrexate (MTX) in patients with moderate to severe active Rheumatoid Arthritis (RA) who…
- Trial name
- NCT03813199
- Testing
- ABX464 50mg, ABX464 100mg, Methotrexate
- Where
- 24 sites in Belgium, Czechia and 3 more
- Volunteers
- 60 people
- Sponsor
- Abivax S.A.
Psoriatic Arthritis
Safety and Efficacy Study of Adalimumab in Patients With Active Psoriatic Arthritis (PsA)
The purpose of the study is to assess the safety and clinical efficacy of adalimumab in active psoriatic arthritis (PsA) subjects when adalimumab is added to insufficient standard therapy including patients that have failed other…
- Trial name
- STEREO (NCT00235885)
- Testing
- adalimumab
- Where
- United States
- Volunteers
- 445 people
- Sponsor
- Abbott
Rheumatoid Arthritis
PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis
A randomised, double blind, parallel group, multicentre study yo compare the pharmacokinetics, pharmacokinetics, safety and efficacy of SAIT101 versus MabThera® versus Rituxan® in patients with rheumatoid arthritis.
- Trial name
- NCT02819726
- Testing
- SAIT101, MabThera, Rituxan
- Where
- 75 sites in United States, Bosnia and Herzegovina and 9 more
- Volunteers
- 294 people
- Sponsor
- Archigen Biotech Limited
Primary Biliary Cholangitis, Primary Biliary Cirrhosis
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy.
- Conditions
- Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Cholangitis, Cholestasis
- Trial name
- PRONTO-PBC (NCT04604652)
- Testing
- HTD1801 (BUDCA)
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Major Depressive Disorder
A Clinical Trial of Adjunctive and Monotherapy PRAX-114 in Participants With Major Depressive Disorder
This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of 10, 20, 40 and 60 mg oral PRAX-114 compared to placebo in the treatment of adults with MDD.
- Trial name
- NCT04969510
- Testing
- 10 mg PRAX-114, 20 mg PRAX-114, 40 mg PRAX-114
- Where
- 24 sites in United States, Australia
- Volunteers
- 110 people
- Sponsor
- Praxis Precision Medicines
Rheumatoid Arthritis
A Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis
This study includes two periods. In Period 1, Participants who meet eligibility criteria will be randomized in a 1:1:1 ratio to receive a twice-daily oral LNK01001 Dose A or LNK01001 Dose B or a matching placebo for 12 weeks.
- Trial name
- NCT06099535
- Testing
- LNK01001 Dose A, LNK01001 Dose B
- Where
- China
- Volunteers
- 156 people
- Sponsor
- Lynk Pharmaceuticals Co., Ltd
Japanese Encephalitis
Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination
IC51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during primary immunization.
- Trial name
- NCT01559831
- Testing
- IXIARO
- Where
- United Kingdom
- Volunteers
- healthy volunteers welcome
- Sponsor
- Valneva Austria GmbH
Arthritis, Rheumatoid
A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate
The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis subjects who are methotrexate-inadequate responders (MTX-IR).
- Trial name
- NCT01554696
- Testing
- peficitinib, methotrexate
- Where
- 49 sites in United States, Belgium and 6 more
- Volunteers
- 379 people
- Sponsor
- Astellas Pharma Inc
Major Depressive Disorder
Single IV Dose of GLYX-13 in Patients With Treatment-Resistant Depression
The purpose of this study is to determine whether GLYX-13 reduces depression score in patients with treatment-resistant depression.
- Trial name
- NCT01234558
- Testing
- GLYX-13
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- Naurex, Inc, an affiliate of Allergan plc
Rheumatoid Arthritis
A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDs
The objective of this study was to verify the superiority of ASP015K alone or in combination with disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who…
- Trial name
- NCT02308163
- Testing
- Peficitinib, Etanercept
- Where
- 153 sites in Japan, South Korea and 1 more
- Volunteers
- 509 people
- Sponsor
- Astellas Pharma Inc
Active Polyarticular Juvenile Idiopathic Arthritis
Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA
- Trial name
- NCT01844518
- Testing
- Abatacept
- Where
- 57 sites in United States, Argentina and 10 more
- Volunteers
- 219 people
- Sponsor
- Bristol-Myers Squibb
Primary Biliary Cirrhosis
Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)
Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion.
- Trial name
- NCT04956328
- Testing
- Obeticholic Acid Tablets, UDCA
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Rheumatoid Arthritis
A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment
This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis.
- Trial name
- NCT00810199
- Testing
- tocilizumab [RoActemra/Actemra], methotrexate
- Where
- 137 sites in United States, Brazil and 18 more
- Volunteers
- 556 people
- Sponsor
- Hoffmann-La Roche