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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
Associated Therapies
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Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy

Phase 3
Completed
Conditions
Gastrointestinal Complications
Diarrhea
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
Other: placebo
Drug: sulfasalazine
First Posted Date
2010-09-09
Last Posted Date
2020-05-12
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
87
Registration Number
NCT01198145
Locations
🇺🇸

Boulder Community Hospital, Boulder, Colorado, United States

🇺🇸

Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States

🇺🇸

St. Joseph Hospital, Denver, Colorado, United States

and more 252 locations

Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2010-07-30
Last Posted Date
2019-01-22
Lead Sponsor
P. Verschueren
Target Recruit Count
400
Registration Number
NCT01172639
Locations
🇧🇪

Reuma instituut Hasselt, Hasselt, Belgium

🇧🇪

ZNA Jan Palfijn, Merksem, Belgium

🇧🇪

Henri Serruys ziekenhuis, Oostende, Belgium

and more 14 locations

Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis

Phase 2
Conditions
Early Ankylosing Spondylitis
First Posted Date
2009-04-29
Last Posted Date
2009-04-29
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
80
Registration Number
NCT00889694

Enbrel-Sulfasalazin-Early-Axial Spondyloarthritis (AS)

Phase 2
Conditions
Moderate to Severe Active Axial Spondyloarthritis
Interventions
First Posted Date
2009-02-13
Last Posted Date
2009-02-13
Lead Sponsor
Charite University, Berlin, Germany
Target Recruit Count
80
Registration Number
NCT00844142
Locations
🇩🇪

Charité Campus Mitte, Rheumatology, Berlin, Germany

🇩🇪

Praxis Mielke, Berlin, Germany

🇩🇪

Waldkrankenhaus, Berlin, Germany

and more 6 locations

Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis

Phase 4
Terminated
Conditions
Arthritis, Juvenile Rheumatoid
Interventions
First Posted Date
2008-03-18
Last Posted Date
2017-02-23
Lead Sponsor
Pfizer
Target Recruit Count
2
Registration Number
NCT00637780
Locations
🇲🇽

Private Office, Guadalajara, Jalisco, Mexico

🇺🇸

University Hospitals Case Medical Center, Cleveland, Ohio, United States

Sulfasalazine and Endothelial Function

Not Applicable
Completed
Conditions
Coronary Artery Disease
First Posted Date
2007-11-06
Last Posted Date
2008-05-15
Lead Sponsor
Boston University
Target Recruit Count
60
Registration Number
NCT00554203
Locations
🇺🇸

Boston Medical Center, Boston, Massachusetts, United States

Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy

Not Applicable
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2006-11-30
Last Posted Date
2013-12-03
Lead Sponsor
US Department of Veterans Affairs
Target Recruit Count
353
Registration Number
NCT00405275
Locations
🇺🇸

VA Medical Center, Loma Linda, Loma Linda, California, United States

🇺🇸

VA Pittsburgh Health Care System, Pittsburgh, Pennsylvania, United States

🇺🇸

Geisinger Medical Group - State College, State College, Pennsylvania, United States

and more 34 locations

Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2005-11-29
Last Posted Date
2014-07-17
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
755
Registration Number
NCT00259610
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

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