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Sulfasalazine

Generic Name
Sulfasalazine
Brand Names
Azulfidine, Salazopyrin, Salazopyrin En-tabs
Drug Type
Small Molecule
Chemical Formula
C18H14N4O5S
CAS Number
599-79-1
Unique Ingredient Identifier
3XC8GUZ6CB
Background

Sulfasalazine is an anti-inflammatory drug structurally related to salicylates and other non-steroidal anti-inflammatory drugs. It is indicated for managing inflammatory diseases such as ulcerative colitis and rheumatoid arthritis (RA). Metabolized by intestinal bacteria, sulfasalazine is broken down into mesalazine and sulfapyridine, 2 compounds that carry out the main pharmacological activity of sulfasalazine.

Sulfasalazine was first used in 1940 for rheumatic polyarthritis, and has been firmly established itself as one fo the most useful disease-modifying antirheumatic drug (DMARD). Compared to the first line treatment of RA like methotrexate, sulfasalazine is almost as efficacious as methotrexate although with slightly less tolerability. However, sulfasalazine has less teratogenic side effects and faster onset of action compared to conventional DMARD. Sulfasalazine fell out of favor as the drug of choice for RA due to poorly designed clinical trials in 1950 but regained interest from the clinical community in the late 1970.

Although sulfasalazine is only approved by the FDA for ulcerative colitis, research have shown that sulfasalazine is also beneficial for patients with Crohn's disease. Meta-analysis of 19 randomized controlled trials indicated that sulfasalazine is superior to placebo in inducing remission; however, with no supported evidence of mucosal healing, sulfasalazine is not FDA-recommmended for treatment of Crohn's disease.

Indication

In the US, sulfasalazine is indicated to treat mild to moderate ulcerative colitis and to prolong the remission period between acute attacks of ulcerative colitis. Sulfasalazine is also indicated as an adjunct therapy in severe ulcerative colitis.For the delayed-release tablet formulation, sulfasalazine is also indicated to treat rheumatoid arthritis in pediatric patients who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs or polyarticular-course juvenile rheumatoid arthritis with the same patients' characteristics.

Associated Conditions
Crohn's Disease (CD), Distal Ulcerative Colitis, Mild to Moderate Ulcerative Colitis, Polyarticular juvenile rheumatoid arthritis, chronic or unspecified, Proctitis, Rheumatoid Arthritis, Severe Ulcerative Colitis, Ulcerative Colitis in Remission

Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial

Phase 4
Completed
Conditions
Psoriatic Arthritis
Interventions
First Posted Date
2018-11-14
Last Posted Date
2025-01-24
Lead Sponsor
University of Oxford
Target Recruit Count
206
Registration Number
NCT03739853
Locations
🇬🇧

Oxford University Hospitals NHS Trust, Oxford, Oxfordshire, United Kingdom

Gastrointestinal Nutrient Transit and Enteroendocrine Function After Upper Gastrointestinal Surgery

Completed
Conditions
Nutrition Disorders
Dumping Syndrome
Appetite Disorders
Delayed Gastric Emptying
Esophageal Cancer
Surgery
Interventions
Diagnostic Test: Duodenal biopsy
Drug: Saline Solution
First Posted Date
2018-11-08
Last Posted Date
2021-08-16
Lead Sponsor
St. James's Hospital, Ireland
Target Recruit Count
40
Registration Number
NCT03734627
Locations
🇮🇪

Department of Surgery, St. James's Hospital, Dublin, Ireland

🇮🇪

Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital, Dublin, Ireland

Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis

Phase 2
Recruiting
Conditions
Primary Sclerosing Cholangitis
Interventions
Drug: Placebo
First Posted Date
2018-06-19
Last Posted Date
2024-04-22
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
42
Registration Number
NCT03561584
Locations
🇺🇸

Brigham and Women's Hospital, Chestnut Hill, Massachusetts, United States

Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis

First Posted Date
2018-02-28
Last Posted Date
2022-04-28
Lead Sponsor
Sanofi
Target Recruit Count
84
Registration Number
NCT03449758
Locations
🇫🇷

Investigational Site Number 250014, Caen, France

🇫🇷

Investigational Site Number 250006, Besancon, France

🇫🇷

Investigational Site Number 250016, Bordeaux, France

and more 30 locations

Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients

Recruiting
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2018-02-22
Last Posted Date
2022-05-04
Lead Sponsor
Vastra Gotaland Region
Target Recruit Count
2500
Registration Number
NCT03440892
Locations
🇸🇪

Dept of Rheumatology and Inflammation research, Gothenburg, Sweden

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

First Posted Date
2018-01-30
Last Posted Date
2025-04-29
Lead Sponsor
University of Nebraska
Target Recruit Count
400
Registration Number
NCT03414502
Locations
🇺🇸

University of Nebraska Medical Center, Omaha, Nebraska, United States

Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Stiffness, Aortic
Endothelial Dysfunction
Cardiovascular Risk Factor
Interventions
First Posted Date
2017-08-18
Last Posted Date
2025-02-26
Lead Sponsor
Flinders University
Target Recruit Count
124
Registration Number
NCT03254589
Locations
🇦🇺

Southern Adelaide Local Health Network, Bedford Park, South Australia, Australia

Oral Pharmacokinetics of Sulfasalazine, Paracetamol, Fexofenadine and Valsartan Using Different Administration Mediums

Phase 1
Completed
Conditions
Administration, Oral
Pharmacokinetics
Magnetic Resonance Imaging
Interventions
Device: non-caloric water
Device: caloric drink
Device: grapefruit juice
First Posted Date
2017-01-06
Last Posted Date
2017-01-06
Lead Sponsor
University Medicine Greifswald
Target Recruit Count
9
Registration Number
NCT03012763

Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy

First Posted Date
2016-10-12
Last Posted Date
2021-07-27
Lead Sponsor
Jawaharlal Institute of Postgraduate Medical Education & Research
Target Recruit Count
136
Registration Number
NCT02930343
Locations
🇮🇳

Department of Clinical Immunology , Jawaharlal Institute of Post graduate Medical Educationa and Research, Pondicherry, India

Dose Reduction of Etanercept in Patients With Ankylosing Spondylitis

First Posted Date
2015-12-23
Last Posted Date
2015-12-28
Lead Sponsor
Zhixiang Huang
Target Recruit Count
100
Registration Number
NCT02638896
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