Immune System Diseases

All Conditions

Symptoms and General Pathology

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Autoimmune Diseases

Necrosis

Arthritis

Arthritis, Rheumatoid

Rheumatic Diseases

Joint Diseases

Collagen Diseases

Connective Tissue Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Dermatologic Agents

Gastrointestinal Agents

Infliximab

Tumor Necrosis Factor Inhibitors

A vial containing powder for concentrate for solution for infusion. Each vial contains: Infliximab 100 mg

Biosimilar Infliximab

The purpose of this observational study is to assess the safety and effectiveness of biosimilar Infliximab in patients with rheumatoid arthritis(RA) in Jordan where no visits or intervention(s) additional to the daily practice will be performed

A multi-center, observational, prospective, cohort study to assess the safety and effectiveness of biosimilar Infliximab (Remsima®) in patients with rheumatoid arthritis in Jordan. Biologic naïve patients will receive Remsima® in accordance with standard medical care and the approved label and will be followed over a period of 34 weeks (8.5 months). Outcomes including occurrence of adverse events (AEs), mean changes in disease activity and health assessment in each cohort will be measured and compared

Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan

Post-Authorization Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan

Rate of AEs leading to permanent treatment discontinuation and rate of clinically relevant changes in laboratory tests will be calculated

The Disease Activity Score (DAS) measures the disease activity in patients with Rheumatoid Arthritis (RA). DAS28 is a validated simplified tool in which twenty-eight joints are measured. The number of swollen joints will be assessed.

The Disease Activity Score (DAS) measures the disease activity in patients with Rheumatoid Arthritis (RA). DAS28 is a validated simplified tool in which twenty-eight joints are measured. The number of tender joints will be assessed.

The Disease Activity Score (DAS) measures the disease activity in patients with Rheumatoid Arthritis (RA). DAS28 is a validated simplified tool in which twenty-eight joints are measured.

ESR (Erythrocyte Sedimentation Rate) will be measured in mm/hr.

The Disease Activity Score (DAS) measures the disease activity in patients with Rheumatoid Arthritis (RA). DAS28 is a validated simplified tool in which twenty-eight joints are measured.

Patients will be asked to make a global assessment of disease activity on a 100 mm Visual Analogue Scale (VAS) measured by units on scale.

Number of swollen and tender joints, Erythrocyte Sedimentation Rate and global assessment of disease activity on a 100 mm Visual Analogue Scale (VAS) are then fed into a complex mathematical formula to produce the overall disease activity score.

The DAS28 provides a number on a scale from 0 to 10 indicating the current activity of the RA of the patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.

The Health assessment questionnaire disability index (HAQ-DI) is a questionnaire for the assessment of Rheumatoid Arthritis. The reported data from patients include the amount of difficulty they have in performing some of their activities. Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3).

Syneos Health

Hikma Pharmaceuticals LLC

Digestive System Diseases

Crohn Disease

Inflammatory Bowel Diseases

Intestinal Diseases

Colitis

Colitis, Ulcerative

Ulcer

Gastroenteritis

Gastrointestinal Diseases

Colonic Diseases

Patients who received at least one dose of Infliximab reference medicinal product (RMP) before the first infusion of Remsima®

The purpose of this observational study is to assess the safety and effectiveness of biosimilar Infliximab in patients with inflammatory bowel disease (IBD) in Saudi Arabia where no visits or intervention(s) additional to the daily practice will be performed.

A multicenter, observational, prospective, cohort study to assess the safety and effectiveness of biosimilar Infliximab (Remsima®) in newly diagnosed and in switched IBD patients diagnosed with active Crohn's disease (CD), fistulizing CD, or Ulcerative Colitis (UC). Each patient is expected to be treated for a total of 38 weeks if naive or 40 weeks if switched. The study duration will be between 46 and 48 weeks (up to 12 months). Follow-up is expected to end 8 weeks after the last treatment visit.

Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients

An Observational, Prospective Cohort Study to Evaluate the Safety and Effectiveness of Remsima® in the Treatment of Inflammatory Bowel Disease Among Saudi Arabia Patients Diagnosed With Crohn's Disease, Ulcerative Colitis, or Fistulizing CD

Number, type, severity and frequency of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests (according to laboratory reference ranges), in addition to the incidence of latent tuberculosis (TB) activation (as an adverse event) and the incidence of hepatitis B virus HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) will be assessed

Clinical response is defined by a decrease in CDAI score from baseline of at least 70 points (Response-70). Clinical remission score \< 150 for naïve patients with CD

Disease control is defined as the absence of disease worsening, with worsening defined as increase in CDAI of 70 points or more from the qualifying score with a total score of 175 or more and an increase in CDAI of 35% or more from baseline, or the introduction of a new treatment for active CD

Clinical response is defined as reduction of at least 50% from baseline in the number of draining fistulas. Clinical remission is defined as the absence of draining fistulas

Disease control is defined as no loss of response, with loss of response defined as the recrudescence of draining fistulas, the need for a change in medication for CD, the need for additional therapy for persistent or worsening luminal disease activity, the need for a surgical procedure for CD, or the discontinuation of study medication owing to a perceived lack of effectiveness

Clinical response is defined as a decrease in partial Mayo scores from baseline of 2 points or more and 30% or more, with an accompanying decrease in the subscore for rectal bleeding of 1 point or more, or an absolute subscore for rectal bleeding of 0 or 1). Clinical remission is defined as a total partial Mayo score of 2 points or less, with no individual sub-score of more than 1 point), Mucosal healing (assessed through endoscopy, and defined by Mayo endoscopic subscore of 1 point or less)

Disease control is defined as the absence of disease worsening, with worsening defined by an increase in partial Mayo score of 3 points or more from baseline \[before switching\] and a partial Mayo score of 5 points or more).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan	NCT03348046	Rheumatoid Arth...	Biosimilar Infl...	18 Years -	Hikma Pharmaceuticals LLC
Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients	NCT03452501	Inflammatory Bo... Crohn Disease Fistulizing Cro... Ulcerative Coli...	Infliximab	18 Years -	Hikma Pharmaceuticals LLC
Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients	NCT03452501	Inflammatory Bo... Crohn Disease Fistulizing Cro... Ulcerative Coli...	Infliximab	18 Years -	Hikma Pharmaceuticals LLC
Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients	NCT03452501	Inflammatory Bo... Crohn Disease Fistulizing Cro... Ulcerative Coli...	Infliximab	18 Years -	Hikma Pharmaceuticals LLC

Spots Global Cancer Trial Database for remsima

Every month we try and update this database with for remsima cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for remsima

Every month we try and update this database with for remsima cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for remsima cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.