Clinical trials: Normal Responders
Rheumatoid Arthritis
Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis
This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)
- Trial name
- NCT00487825
- Testing
- Canakinumab (investigational), Methotrexate (MTX)
- Where
- 22 sites in United States, Belgium and 4 more
- Volunteers
- 78 people
- Sponsor
- Novartis
Rheumatoid Arthritis
Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants
The primary objective of the study was to evaluate the long-term safety and tolerability of filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis.
- Trial name
- DARWIN3 (NCT02065700)
- Testing
- Filgotinib
- Where
- 111 sites in United States, Argentina and 20 more
- Volunteers
- 739 people
- Sponsor
- Lakefront Biotherapeutics NV
Infertility
Follicular Activation in Poor Responders
This study aims to assess whether activation of primordial follicles through ovarian cortex fragmentation may increase the number of antral follicles present in the ovary of patients with diminished ovarian reserve.
- Trial name
- FAPPOR (NCT02354963)
- Testing
- In vitro fragmentation of the ovarian tissue
- Where
- Spain
- Volunteers
- 34 people
- Sponsor
- César Díaz García
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
Atopic Dermatitis
Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis
This was a parallel treatment, Phase 2, double-blind, 2-arm, placebo-controlled study with 2 staggered cohorts (2 arms in each cohort) to evaluate the efficacy and safety of rilzabrutinib in adult participants (aged at least 18…
- Trial name
- NCT05018806
- Testing
- Rilzabrutinib
- Where
- 31 sites in United States, Canada and 5 more
- Volunteers
- 124 people
- Sponsor
- Sanofi
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Pemphigus Vulgaris, Multiple Sclerosis (MS)
- Trial name
- NCT05000216
- Testing
- Moderna mRNA-1273, BNT162b2, Ad26.COV2.S
- Where
- 29 sites in United States
- Volunteers
- 258 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Rheumatoid Arthritis
An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Sero-Positive Rheumatoid Arthritis Who Are Non-Responders or Intolerant to a Single TNF-Inhibitor (PORTSMAB)
This observational study will assess the long-term efficacy and safety of MabThera/Rituxan in routine clinical practice in patients with sero-positive rheumatoid arthritis who are non-responders or intolerant to a single tumour…
- Trial name
- NCT01309282
- Where
- Portugal
- Volunteers
- 9 people
- Sponsor
- Hoffmann-La Roche
Chronic Spontaneous Urticaria
Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)
Primary Objective: This study aimed to demonstrate the efficacy of dupilumab in study participants with CSU who remained symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab…
- Trial name
- NCT04180488
- Testing
- Dupilumab SAR231893, non sedating H1-antihistamine
- Where
- 98 sites in United States, Argentina and 9 more
- Volunteers
- 397 people
- Sponsor
- Sanofi
Rheumatoid Arthritis
Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to Cimzia
Purpose of the study is to determine if Cimzia is safe and effective in subjects who have received previous treatment with a TNF-alpha inhibitor other than Cimzia.
- Trial name
- NCT01147341
- Testing
- Cimzia
- Where
- 12 sites in United States
- Volunteers
- 37 people
- Sponsor
- Michael Schiff, MD
Rheumatoid Arthritis
A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)
Primary Objective: -To demonstrate that sarilumab added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Japanese RA participants with an inadequate response to MTX.
- Trial name
- NCT02293902
- Testing
- Sarilumab SAR153191 (REGN88), Methotrexate, Folic acid
- Where
- 96 sites in Japan
- Volunteers
- 243 people
- Sponsor
- Sanofi
Rheumatoid Arthritis
To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)
Primary Objective: To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.
- Trial name
- NCT01768572
- Testing
- sarilumab SAR153191 (REGN88), tocilizumab, hydroxychloroquine
- Where
- 78 sites in United States, Argentina and 17 more
- Volunteers
- 202 people
- Sponsor
- Sanofi
Rheumatoid Arthritis
Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders
This study is a pilot, proof of concept study to determine the effects of administering an oral short-chain fatty acid (SCFA) supplement to Rheumatoid Arthritis (RA) patients with inadequate response to methotrexate (MTX).
- Trial name
- EASi-RAIR (NCT05718583)
- Testing
- Butyrate
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- NYU Langone Health
Arthritis, Rheumatoid
Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor
Phase 2 study of the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of KPL-404 in subjects with moderate to severe Rheumatoid Arthritis.
- Trial name
- NCT05198310
- Testing
- KPL-404
- Where
- 42 sites in United States, Bulgaria and 5 more
- Volunteers
- 145 people
- Sponsor
- Kiniksa Pharmaceuticals, Ltd.
Rheumatoid Arthritis
An Observational Study of MabThera/Rituxan (Rituximab) and Alternative TNF-Inhibitors in Patients With Rheumatoid Arthritis and an Inadequate Response to a Single Previous TNF-Inhibitor
This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single…
- Trial name
- NCT01557348
- Where
- 215 sites in Canada, Colombia and 10 more
- Volunteers
- 1,239 people
- Sponsor
- Hoffmann-La Roche
Arthritis, Rheumatoid
COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA
In the Care in Rheumatoid Arthritis (CareRA) trial (NCT01172639) about 70% of early RA patients are in remission at the 2 year evaluation point independent of the combination scheme used.
- Trial name
- CareRA2020 (NCT03649061)
- Testing
- Etanercept 50 MG/ML, Leflunomide 10 milligram (MG)
- Where
- 19 sites in Belgium
- Volunteers
- 276 people
- Sponsor
- P. Verschueren
Rheumatoid Arthritis
To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)
Primary Objective: To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) were effective for: reduction of signs and symptoms at Week 24 and improvement of physical function at Week 12 in…
- Trial name
- NCT01709578
- Testing
- Sarilumab, hydroxychloroquine, methotrexate
- Where
- 196 sites in United States, Argentina and 28 more
- Volunteers
- 546 people
- Sponsor
- Sanofi
Moderate to Severe Plaque-type Psoriasis
Secukinumab Dosage Optimisation in Partial Responders With Moderate to Severe Plaque-type Psoriasis
This study is designed to support the optimal use of secukinumab by providing data to refine guidance on dosing flexibility in patients with psoriasis.
- Trial name
- GAIN (NCT02474069)
- Testing
- Secukinumab
- Where
- 89 sites in Germany
- Volunteers
- 772 people
- Sponsor
- Novartis Pharmaceuticals
Plaque-type Psoriasis
Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis
The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.
- Trial name
- STATURE (NCT01412944)
- Testing
- secukinumab 150mg, secukinumab 10mg/kg i.v. regimen
- Where
- 27 sites in United States, Austria and 6 more
- Volunteers
- 43 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis
Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients
Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks.
- Trial name
- RA-MOBILITY (NCT01061736)
- Testing
- Sarilumab, Methotrexate, Folic Acid
- Where
- 262 sites in United States, Argentina and 34 more
- Volunteers
- 1,675 people
- Sponsor
- Sanofi
Rheumatoid Arthritis
Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis
The purpose of the study is to evaluate the effectiveness of four dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding.
- Trial name
- OSKIRA-Asia-1 (NCT01569074)
- Testing
- Fostamatinib
- Where
- 34 sites in Hong Kong, Japan and 4 more
- Volunteers
- 163 people
- Sponsor
- AstraZeneca