Comparison of MTX+Anti-TNF to MTX+Conventional DMARDs in Patients With Early Rheumatoid Arthritis (RA) Who Failed MTX Alone (SWEFOT) (SWEFOT)
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ClinicalTrials.gov Identifier: NCT00764725 |
Recruitment Status :
Completed
First Posted : October 2, 2008
Last Update Posted : December 23, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Drug: conventional DMARD combination Biological: MTX plus anti-TNF | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 487 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective Randomized, Open, Multi-Center Trial Comparing TNF-Blockade + MTX to MTX+SSZ+HCQ in Patients With Early RA With an Inadequate Response to MTX |
Study Start Date : | December 2002 |
Actual Primary Completion Date : | April 2007 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: A
MTX+SSZ+Plaquenil
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Drug: conventional DMARD combination
MTX+SSZ+Plaquenil; can be changed to MTX+cyclosporin within protocol
Other Name: MTX=Methotrexate, SSZ=Sulfasalazine, Plaquenil=HCQ |
Active Comparator: B
MTX+Infliximab
|
Biological: MTX plus anti-TNF
MTX + infliximab; can be changed to MTX + etanercept within protocol
Other Name: infliximab=Remicade |
- EULAR individual response [ Time Frame: 12 months ]
- All core set variables; function; x-ray; health-economic [ Time Frame: 6-24 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- RA, symptom duration < 12 months
Exclusion Criteria:
- Contraindication to any of the trial medications

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764725
Principal Investigator: | Johan Bratt, MD PhD | Karolinska University Hospital |
Responsible Party: | Dr. Johan Bratt, Karolinska University Hospital |
ClinicalTrials.gov Identifier: | NCT00764725 |
Other Study ID Numbers: |
P0 3013 Swefot |
First Posted: | October 2, 2008 Key Record Dates |
Last Update Posted: | December 23, 2008 |
Last Verified: | December 2008 |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Sulfasalazine Methotrexate Infliximab Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Gastrointestinal Agents Anti-Infective Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |