MedPath

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

Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis

Phase 2
Conditions
Ankylosing Spondylitis
Interventions
Biological: TNF alpha
First Posted Date
2015-05-28
Last Posted Date
2015-05-28
Lead Sponsor
Chung Shan Medical University
Target Recruit Count
300
Registration Number
NCT02456363
Locations
🇨🇳

Chung Shan Medical University Hospital, Taichung, Taiwan

An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects

Phase 1
Completed
Conditions
Chemotherapy-induced Nausea and Vomiting
Interventions
First Posted Date
2015-05-05
Last Posted Date
2015-08-25
Lead Sponsor
Tesaro, Inc.
Target Recruit Count
102
Registration Number
NCT02434861
Locations
🇺🇸

Parexel Early Phase Unit, Baltimor, Maryland, United States

Very Early Versus Delayed Etanercept in Patients With RA

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2015-05-04
Last Posted Date
2019-09-09
Lead Sponsor
University of Leeds
Target Recruit Count
120
Registration Number
NCT02433184
Locations
🇬🇧

Institute of Rheumatic & Musculoskeletal Medicine, Chapel Allerton Hospital, Leeds, West Yorkshire, United Kingdom

Treatments Against RA and Effect on FDG-PET/CT

First Posted Date
2015-02-27
Last Posted Date
2022-10-26
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
159
Registration Number
NCT02374021
Locations
🇺🇸

IRIS Research and Development, Plantation, Florida, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

and more 28 locations

A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)

First Posted Date
2015-02-26
Last Posted Date
2018-01-30
Lead Sponsor
Sanofi
Target Recruit Count
91
Registration Number
NCT02373202
Locations
🇯🇵

Investigational Site Number 392039, Fukuoka-Shi, Japan

🇯🇵

Investigational Site Number 392006, Sasebo-Shi, Japan

🇯🇵

Investigational Site Number 392023, Takaoka-Shi, Japan

and more 37 locations

To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

Phase 3
Completed
Conditions
RA
Interventions
Device: Auto-Injector Device (AID)
Device: Pre-filled Syringe (PFS)
First Posted Date
2014-02-07
Last Posted Date
2017-06-20
Lead Sponsor
Sanofi
Target Recruit Count
217
Registration Number
NCT02057250
Locations
🇨🇱

Investigational Site Number 152050, Santiago, Chile

🇨🇱

Investigational Site Number 152007, Viña Del Mar, Chile

🇲🇽

Investigational Site Number 484005, Monterrey, Mexico

and more 50 locations

A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis

First Posted Date
2013-09-13
Last Posted Date
2018-11-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
100
Registration Number
NCT01941095
Locations
🇬🇷

Laiko General Hospital; Dept. of Pathophysiology-Uni of Athens, Athens, Greece

🇬🇷

Uni Hospital of Ioannina; Rheumatology, Ioannina, Greece

🇬🇷

General Hospital of Thessaloniki HIPPOKRATIO; Clinical Immunology Unit,2nd Dept of Internal Medicine, Thessaloniki, Greece

and more 7 locations

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)

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2013-01-15
Last Posted Date
2017-06-26
Lead Sponsor
Sanofi
Target Recruit Count
202
Registration Number
NCT01768572
Locations
🇺🇸

Investigational Site Number 840033, Fort Lauderdale, Florida, United States

🇺🇸

Investigational Site Number 840150, Lansing, Michigan, United States

🇺🇸

Investigational Site Number 840022, Dallas, Texas, United States

and more 75 locations

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)

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2012-10-18
Last Posted Date
2017-08-08
Lead Sponsor
Sanofi
Target Recruit Count
546
Registration Number
NCT01709578
Locations
🇺🇸

Investigational Site Number 840018, Idaho Falls, Idaho, United States

🇺🇸

Investigational Site Number 840058, Columbia, South Carolina, United States

🇺🇸

Investigational Site Number 840124, Clarksburg, West Virginia, United States

and more 193 locations
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