Clinical trials: Biotherapy
Polyarthritis; Rheumatoid
Performance of PEAR 2.0 Software in Prescribing Biotherapy in Patients With Rheumatoid Arthritis
The management of rheumatoid arthritis is based on the prescription of disease-modifying anti-rheumatic drugs (DMARDs) to induce clinical and biological remission.
- Trial name
- NCT06186375
- Testing
- Patients with planned biotherapy
- Where
- 4 sites in France
- Volunteers
- 239 people
- Sponsor
- CEN Biotech
Rheumatoid Arthritis
Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line Biological Therapy of Patients With Active Rheumatoid Arthritis
The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA seropositive previously untreated with…
- Trial name
- ALTERRA (NCT02744196)
- Testing
- Acellbia, Methotrexate
- Volunteers
- 159 people
- Sponsor
- Biocad
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.
Asthma
Change in Patient-Reported Outcomes in Severe Eosinophilic Asthma Patients Treated With Benralizumab Under Real-life Conditions
The main aim of this study is to investigate the change in asthma control after 6 months of therapy in patients treated with benralizumab biologic therapy for severe eosinophilic asthma under real-life conditions in a pulmonary…
- Trial name
- imPROve (NCT04184284)
- Where
- 50 sites in Germany
- Volunteers
- 246 people
- Sponsor
- AstraZeneca
Rheumatoid Arthritis
Retention Rates of Adalimumab, Etanercept and Infliximab as First and Second-Line Biotherapy in Patients With Rheumatoid Arthritis in Daily Practice
To compare retention rates of adalimumab, etanercept and infliximab as first-line biotherapy in rheumatoid arthritis (RA), to determine causes of discontinuation, retention-associated factors, and retention rates of possible…
- Trial name
- MAINTAIN (NCT01692899)
- Volunteers
- 780 people
- Sponsor
- Pfizer
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
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.
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.
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
Ulcerative Colitis
Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).
- Trial name
- U-ASTOUND (NCT05782907)
- Testing
- Upadacitinib
- Where
- 89 sites in United States, Australia and 21 more
- Volunteers
- 122 people
- Sponsor
- AbbVie
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
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.
Rheumatoid Arthritis
Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year
This multicenter, prospective, non-interventional study is designed to obtain an accurate estimation of the drug retention rate of Tocilizumab (TCZ) Subcutaneously (SC) under real-world conditions in participants with moderate to…
- Trial name
- NCT02608112
- Testing
- Methotrexate, Tocilizumab
- Where
- 77 sites in France
- Volunteers
- 291 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
Crohn's Disease
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels.
- Trial name
- U-EMPOWER (NCT06332534)
- Testing
- Upadacitinib
- Where
- 85 sites in United States, Australia and 16 more
- Volunteers
- 111 people
- Sponsor
- AbbVie
Melanoma (Skin)
Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV…
- Trial name
- NCT00012064
- Testing
- therapeutic autologous dendritic cells
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Lisata Therapeutics, Inc.
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
Dermatitis Atopic
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate…
- Trial name
- AQUA (NCT06241118)
- Testing
- Amlitelimab, Topical corticosteroids, Topical tacrolimus or pimecrolimus
- Where
- 154 sites in United States, Argentina and 20 more
- Volunteers
- 464 people
- Sponsor
- Sanofi
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.
Diabetic Foot Infection, Non-healing Wound
Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU)
It is hypothesized that application at 4-week or greater intervals of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer (DFU) will, with concomitant management of…
- Conditions
- Diabetic Foot Infection, Non-healing Wound, Non-healing Diabetic Foot Ulcer
- Trial name
- NCT04176120
- Testing
- TTAX01, Standard Care
- Where
- 16 sites in United States
- Volunteers
- 220 people
- Sponsor
- BioTissue Holdings, Inc