Clinical trials: Biotherapy
Leukemia, Hairy Cell
Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia
Background: Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It targets CD22, a molecule on the surface of essentially all hairy cell leukemia cells.
- Trial name
- NCT01829711
- Testing
- Moxetumomab pasudotox, IV Bag Protectant for Moxetumomab pasudotox
- Where
- 34 sites in United States, Belgium and 12 more
- Volunteers
- 80 people
- Sponsor
- MedImmune LLC
Rheumatoid Arthritis
A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic Therapy
This two part, multi-center, open-label, single-arm study will evaluate the efficacy and safety of tocilizumab as a monotherapy or in combination with methotrexate or other conventional synthetic disease modifying antirheumatic…
- Trial name
- TOSCA (NCT02001987)
- Testing
- Tocilizumab, Methotrexate, csDMARDs
- Where
- 32 sites in France
- Volunteers
- 139 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis
A Canadian study to evaluate early use of adalimumab after methotrexate failure in early rheumatoid arthritis. The study hypothesis will verify if adalimumab effectively reduces joint damage in more participants when introduced…
- Trial name
- RADAR (NCT01162421)
- Testing
- adalimumab, Methotrexate
- Volunteers
- 77 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Psoriatic Arthritis (PsA)
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)
The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).
- Trial name
- KEEPsAKE2 (NCT03671148)
- Testing
- Risankizumab
- Where
- 138 sites in United States, Argentina and 23 more
- Volunteers
- 444 people
- Sponsor
- AbbVie
Crohn Disease
Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC
The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's…
- Trial name
- NCT00094458
- Testing
- infliximab (IFX) infusion; azathioprine (AZA) caps
- Where
- 115 sites in United States, Austria and 13 more
- Volunteers
- 508 people
- Sponsor
- Centocor Ortho Biotech Services, L.L.C.
Systemic Lupus Erythematosus
A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to assess the impact of belimumab on immune response to pneumococcal vaccine in subjects with Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT01597492
- Testing
- Belimumab plus Early Vaccination, Belimumab plus Late Vaccination
- Where
- 15 sites in United States
- Volunteers
- 79 people
- Sponsor
- Human Genome Sciences Inc., a GSK Company
Rheumatoid Arthritis
An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy
This observational multicenter study will evaluate the management of disease and safety in clinical practice in patients with moderate to severe rheumatoid arthritis receiving any biological therapies in monotherapy.
- Trial name
- NCT01664117
- Where
- 41 sites in Spain
- Volunteers
- 210 people
- Sponsor
- Hoffmann-La Roche
Psoriasis
A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612)
Subjects with moderate-to-severe chronic psoriasis not responding to standard or biologic therapy will be eligible to enroll in this study.
- Trial name
- ESAQUALITY (NCT00687401)
- Testing
- Infliximab
- Volunteers
- 215 people
- Sponsor
- Merck Sharp & Dohme LLC
Rheumatoid Arthritis
An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
This prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab) as the first biologic therapy.
- Trial name
- NCT01543503
- Where
- 154 sites in Argentina, Belgium and 14 more
- Volunteers
- 1,225 people
- Sponsor
- Hoffmann-La Roche
EBV-induced Lymphomas, EBV-associated Malignancies
Biological Therapy in Treating Patients at High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies
The purpose of this phase I/II trial is to study the side effects and best dose of biological therapy to treat patients at high-risk or with Epstein-Barr virus-associated lymphoma or lymphoproliferative disease.
- Conditions
- EBV-induced Lymphomas, EBV-associated Malignancies, Transplant Patients With EBV Viremia at High Risk of Developing a Recurrent EBV Lymphoma
- Trial name
- NCT00002663
- Testing
- Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Atara Biotherapeutics
Healthy
Study of Belimumab Administered Subcutaneously to Healthy Subjects
The purpose of this study is to measure the amount of belimumab in the blood when given as an injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of multiple injections under the skin in…
- Trial name
- NCT01583530
- Testing
- Single Dose Group: Belimumab IV 240 mg, Single Dose Group: Belimumab SC 2 x 120 mg, Single Dose Group: Belimumab SC 1 x 240 mg
- Where
- 4 sites in United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Human Genome Sciences Inc.
Ankylosing Spondylitis
Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis
The objective of this observational study is to determine the incidence of response in patients with predictive factors of major clinical response in active ankylosing spondylitis (AS) in patients who start anti-tumor necrosis…
- Trial name
- PRETEA (NCT00900796)
- Testing
- Treatment switching
- Where
- Spain
- Volunteers
- 132 people
- Sponsor
- Pfizer
Crohn's Disease
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).
- Trial name
- NCT03345836
- Testing
- Upadacitinib
- Where
- 428 sites in United States, Argentina and 46 more
- Volunteers
- 624 people
- Sponsor
- AbbVie
Rheumatoid Arthritis
A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy
The primary objective is to compare the safety and efficacy of multiple doses of ABT-494 versus placebo in moderately to severely active RA subjects on stable background MTX therapy with inadequate response or intolerance to…
- Trial name
- NCT01960855
- Testing
- ABT-494
- Volunteers
- 276 people
- Sponsor
- AbbVie
Crohn's Disease
A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).
- Trial name
- U-EXCEL (NCT03345849)
- Testing
- Upadacitinib
- Where
- 432 sites in United States, Argentina and 47 more
- Volunteers
- 526 people
- Sponsor
- AbbVie
Rheumatoid Arthritis
Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of various repeat-dose regimens of KB003 in subjects with active Rheumatoid Arthritis (RA) who have had an inadequate prior treatment…
- Trial name
- NCT00995449
- Testing
- KB003
- Where
- 11 sites in United States
- Volunteers
- 9 people
- Sponsor
- Humanigen, Inc.
Bacterial Pneumonia
Cx611-0204 SEPCELL Study
The purpose of this randomised, multicentre, double-blind, placebo-controlled, phase Ib/IIa study is to assess the safety, tolerability and efficacy of eASCs (Cx611) administered intravenously as adjunctive therapy, therefore in…
- Trial name
- SEPCELL (NCT03158727)
- Testing
- Cx611
- Where
- 33 sites in Belgium, France and 4 more
- Volunteers
- 84 people
- Sponsor
- Tigenix S.A.U.
Plaque Psoriasis
A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis
The purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque psoriasis.
- Trial name
- IXORA-R (NCT03573323)
- Testing
- Ixekizumab, Guselkumab
- Where
- 124 sites in United States, Canada and 1 more
- Volunteers
- 1,027 people
- Sponsor
- Eli Lilly and Company
Focal Epilepsy
A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
Assessment of the efficacy under daily clinical conditions of the new antiepileptic drugs (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and topiramate, used as first-choice combination…
- Trial name
- NCT00855738
- Testing
- Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide
- Volunteers
- 111 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.