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A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 30 mg (QD) and 15 mg QD versus placebo on a background of csDMARD(s) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-…

SIMILAR Trial: Santeon InflixMab biosimILAr Research
A randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission

The objective of this study is to compare the efficacy of Infliximab-biosimilar to Infliximab-innovator and to demonstrate its noninferiority up to 30 weeks, in patients with ulcerative colitis or Crohn*s disease in remission under treatment with…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis

Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis…

A two part, phase 1, randomised, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of GBR 830 in adult healthy volunteers (Part 1) and a randomised, placebo-controlled, pharmacodynamic study to evaluate the effect of single dose of GBR 830 on vaccination response in adult, healthy volunteers (Part 2)

The purpose of this study is to investigate to what extent GBR 830 is tolerated. It will also be investigated how quickly and to what extent GBR 830 is absorbed and eliminated from the body (this is called pharmacokinetics) and to what extent the…

A randomized, double-blind, placebo-controlled trial of golimumab+methotrexate versus methotrexate alone in methotrexate-naïve patients with psoriatic arthritis

1) to demonstrate the safety and efficacy of golimumab + MTX versus MTX alone in DMARD naïve PsA patients2) to demonstrate that golimumab + MTX is superior to MTX alone to achieve low to very low disease activity in DMARD naïve PsA patients3) to…

The Role of Conditioning for Pharmacotherapeutic Treatments in Rheumatoid Arthritis.

This study aims to enhance pharmacotherapeutic effects in patients with recent-onset RA by means of conditioning (via a variable reinforcement schedule).

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

The purpose of this study is to investigate the effectiveness and safety of riociguat (BAY 63-2521) in patients with diffuse cutaneous systemic sclerosis.

Therapeutic drug monitoring in tocilizumab-treated rheumatoid arthritis patients: Pilot study of a double-blind randomised controlled trial

To evaluate the feasibility of the study after 20 weeks of follow-up, which includes the evaluation of the dose-reduction algorithm in tocilizumab-treated patients with RA.

A double-blind randomized placebo-controlled single and multiple ascending doses study of the safety and tolerability, pharmacokinetics (including bioavailability comparison and food effect) and pharmacodynamics of oral BMS-986251 administration in healthy subjects, with efficacy assessment of multiple doses in patients with moderate-to-severe psoriasis

The purpose of Part A of this study is to investigate how safe the new compound BMS 986251 is when it is administered as a single dose to healthy subjects. The purpose of Part B of this study is to investigate how safe the new compound BMS 986251 is…

A multicenter, open-label (Part A) followed by a randomized, double-blind, parallel-group, placebo controlled study (Part B) to evaluate maintenance of remission in subjects with active axial spondyloarthritis (axSpA) receiving either Certolizumab pegol 200mg Q2W or 200mg Q4W as compared to placebo

The primary objective of the study is to evaluate the percentage of subjects who do not experience a flare on CZP 200mg Q2W (full-dose) or 200mg Q4W (half-dose) during Part B. The secondary objectives are: 1) to evaluate the percentage of subjects…

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel Group
Pilot Study to Evaluate the Safety and Efficacy of FFP104 in the Treatment of
Subjects with Moderate to Severely Active Crohn*s Disease

To evaluate the safety and efficacy of intravenously administered FFP104 in subjects with active Crohn*s disease following repeat doses of FFP104.

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects with Active Systemic Lupus Erythematosus

The primary objective of the research is to find out if treatment with BMS-931699 can improve systemic lupus erythematosus (SLE) disease activity. This will be measured by determining the proportion of BICLA responders who achieve BILAG disease…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Period 1:The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD and 30 mg QD versus placebo for the treatment of signs and symptoms of subjects with active RA who are on a stable dose of conventional synthetic disease-…

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

EFFICACY OBJECTIVESThe primary efficacy objective for this study is as follows:* To evaluate the efficacy of TCZ compared with placebo on skin sclerosis, as measured by mRSS at Week 48The secondary efficacy objectives for this study are as follows…

A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) (BEL114055)

Primary: safety and tolerability of belimumab in a pediatric population (5-17 y) with SLE.Secondary: PK, efficacy, quality of life.

A phase 3b, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Study of the Efficacy and Safety of Apremilast (CC-10004), Etanercept, and Placebo, In Subjects with Moderate to Severe Plaque Psoriasis

Primary Objective- To evaluate the clinical efficacy and safety of oral apremilast (APR) 30 mg twice a day (BID) compared with placebo, in subjects with moderate to severe plaque psoriasis at Week 16.Secondary Objectives- To evaluate the clinical…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

Period 1: The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD versus placebo and versus adalimumab for the treatment of signs and symptoms of rheumatoid arthritis in subjects with moderately to severely active RA who are…

Bright light therapy in rheumatoid arthritis to improve symptoms of fatigue and other disease outcomes: a randomized controlled pilot trial.

The primary objective of this pilot trial is to explore the difference between the intervention and control group in change from baseline (T0) to the end of therapy (T1) in therapy efficacy of the primary study outcome fatigue assessed by Checklist…

A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness

Primary Objective:* To evaluate the safety and tolerability of ARGX-113.Secondary Objectives:* To evaluate the clinical effect of ARGX-113 using:-Myasthenia Gravis-Activities of Daily Living (MG-ADL) score.-Quantitative-Myasthenia Gravis score (QMG…

Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors.

Primary Objective:To compare the efficacy of BMS-986142 versus placebo on a background of MTX as assessed by ACR20 and ACR70 response rates at week 12.Secondary Objectives:1) Assess additional efficacy outcomes of BMS-986142 at week 12 and over 12…