Clinical trials: Inadequate Response
Glucose Intolerance
Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)
This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin (MK-0431/ONO-5435) used once daily (qd) in Japanese participants with impaired glucose tolerance who have inadequate glycemic control using…
- Trial name
- NCT01405911
- Testing
- Sitagliptin 25 mg, Sitagliptin 50 mg
- Volunteers
- 242 people
- Sponsor
- Merck Sharp & Dohme LLC
Rheumatoid Arthritis
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.
The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking disease modifying anti-rheumatic drug (DMARD) but not…
- Trial name
- OSKIRA - 2 (NCT01197534)
- Testing
- fostamatinib
- Where
- 149 sites in United States, Canada and 14 more
- Volunteers
- 913 people
- Sponsor
- AstraZeneca
Rheumatoid Arthritis
Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active Rheumatoid Arthritis
The purpose of this study is to determine the efficacy and safety of three different Tregalizumab doses in combination with Methotrexate (MTX) in subjects who have active rheumatoid arthritis and an inadequate response to MTX…
- Trial name
- 986 (NCT01999192)
- Testing
- Tregalizumab
- Where
- 84 sites in United States, Bulgaria and 12 more
- Volunteers
- 321 people
- Sponsor
- Biotest
Psoriatic Arthritis
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants with moderately to severely active psoriatic arthritis (PsA).
- Trial name
- KEEPsAKE 1 (NCT03675308)
- Testing
- Risankizumab
- Where
- 256 sites in United States, Argentina and 37 more
- Volunteers
- 964 people
- Sponsor
- AbbVie
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
Rheumatoid Arthritis
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Participants With Rheumatoid Arthritis (MK-8457-010)
The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate (MTX) in participants with active rheumatoid arthritis (RA) and an inadequate response or intolerance to anti-tumor necrosis factor α…
- Trial name
- NCT01651936
- Testing
- MK-8457 100 mg, Methotrexate
- Volunteers
- 56 people
- Sponsor
- Merck Sharp & Dohme LLC
Active Systemic Lupus Erythematosus
Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus
The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.
- Trial name
- NCT04680637
- Testing
- Efavaleukin Alfa, Standard of Care
- Where
- 150 sites in United States, Austria and 17 more
- Volunteers
- 168 people
- Sponsor
- Amgen
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 Methotrexate
This study [contRAst 1 (201790: NCT03980483)] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165, in combination with methotrexate (MTX), for the treatment of adult…
- Trial name
- contRAst 1 (NCT03980483)
- Testing
- GSK3196165 (Otilimab), Tofacitinib 5 mg
- Where
- 76 sites in China, Hungary and 8 more
- Volunteers
- 1,537 people
- Sponsor
- GlaxoSmithKline
Major Depressive Disorder
Safety and Efficacy Study Comparing ETS6103 With Amitriptyline in the Treatment of Major Depressive Disorder (MDD)
To demonstrate that the antidepressant activity of ETS6103 is not inferior to amitriptyline in subjects who have an unsatisfactory response to / are resistant to treatment with SSRIs.
- Trial name
- ETS6103-003 (NCT02014363)
- Testing
- ETS6103 (low dose), ETS6103 (high dose), Amitriptyline
- Where
- United Kingdom
- Volunteers
- 164 people
- Sponsor
- e-Therapeutics PLC
Psoriatic Arthritis
A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug
This is a Phase 3 multicenter study that included two periods. Period 1 was designed to compare the safety, tolerability, and efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo in participants with…
- Trial name
- SELECT - PsA 2 (NCT03104374)
- Testing
- Upadacitinib
- Where
- 165 sites in United States, Australia and 17 more
- Volunteers
- 642 people
- Sponsor
- AbbVie
Eosinophilic Duodenitis, Eosinophilic Gastroenteritis
A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis
This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002) given monthly for 6 doses in adult patients with active eosinophilic duodenitis.
- Trial name
- EoDyssey (NCT04856891)
- Testing
- AK002
- Where
- 39 sites in United States
- Volunteers
- 94 people
- Sponsor
- Allakos Inc.
Multiple Myeloma, Non-Hodgkins Lymphoma
Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant
Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both healthy volunteers and cancer patients.
- Conditions
- Multiple Myeloma, Non-Hodgkins Lymphoma, Hodgkins Disease
- Trial name
- NCT00901225
- Testing
- G-CSF plus Plerixafor
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Duke University
Major Depressive Disorder (MDD)
Brexpiprazole as Adjunctive Therapy With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy
The objectives of this exploratory trial are to evaluate the efficacy, safety, and subjects' subjective satisfaction when switching to adjunctive brexpiprazole in subjects with MDD who have responded inadequately to preceding…
- Trial name
- NCT02012218
- Testing
- ADT, Brexpiprazole
- Where
- 24 sites in United States
- Volunteers
- 61 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Rheumatoid Arthritis
Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)
The primary objective of this study is to evaluate the efficacy of atacicept compared to placebo in the treatment of signs and symptoms in a subject population with active rheumatoid arthritis (RA), inadequate response to…
- Trial name
- AUGUST II (NCT00595413)
- Testing
- Atacicept: with loading dose, Atacicept, Adalimumab
- Where
- 2 sites in United States, Germany
- Volunteers
- 311 people
- Sponsor
- EMD Serono
Major Depressive Disorder
A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.
- Trial name
- NCT01500200
- Testing
- ALKS 5461
- Where
- 27 sites in United States
- Volunteers
- 142 people
- Sponsor
- Alkermes, Inc.
Rheumatoid Arthritis
Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan
This study will be conducted in Japan, South Korea and Taiwan to evaluate the optimal dosage of methotrexate (MTX) as an add-on therapy to adalimumab (ADA) in participants with rheumatoid arthritis (RA) who have not achieved…
- Trial name
- NCT03505008
- Testing
- Methotrexate, Adalimumab
- Where
- 24 sites in Japan, South Korea and 1 more
- Volunteers
- 300 people
- Sponsor
- Keio University
Chronic Plaque Psoriasis
Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment
The objective of this study is to assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone, vs.
- Trial name
- BELIEVE (NCT00574249)
- Testing
- adalimumab, Calcipotriol/Betamethasone Ointment
- Where
- 131 sites in Austria, Belgium and 13 more
- Volunteers
- 730 people
- Sponsor
- Abbott
Major Depressive Disorder
Levomilnacipran ER vs. Adjunctive Quetiapine for Adults With Inadequate Relief With SSRIs in MDD
This study's primary objective is to compare the efficacy and tolerability of switching patients with inadequate relief on generic SSRIs to levomilnacipran versus adding a new treatment (quetiapine) to the participants' existing…
- Trial name
- NCT02720198
- Testing
- Levomilnacipran, Quetiapine
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Duke University
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to Eculizumab
The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with paroxysmal nocturnal hemoglobinuria (PNH) who have an inadequate response to eculizumab.
- Trial name
- NCT03030183
- Testing
- Zilucoplan (RA101495)
- Where
- 6 sites in United States
- Volunteers
- 3 people
- Sponsor
- Ra Pharmaceuticals
Rheumatoid Arthritis
Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1)
Participants suffering from active rheumatoid arthritis despite continued treatment with methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 (3 different doses - 50 milligram [mg], 100…
- Trial name
- DARWIN1 (NCT01888874)
- Testing
- GLPG0634
- Where
- 142 sites in United States, Argentina and 20 more
- Volunteers
- 599 people
- Sponsor
- Lakefront Biotherapeutics NV