NCT00579878

Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis

Completed Phase 3 Results posted Last updated 2 October 2023

What this trial tests

Phase 3 trial testing Leflunomide in Rheumatoid Arthritis in 69 participants. Completed in 11 March 2010.

Timeline

27 March 2001

Primary endpoint
11 March 2010

11 March 2010

Quick facts

Lead sponsor	University of Nebraska
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	69
Start date	27 March 2001
Primary completion	11 March 2010
Estimated completion	11 March 2010
Sites	1 location across United States

Drugs / interventions tested

• Leflunomide (LEFLUNOMIDE) — full drug profile →
• Methotrexate-Sulfasalazine-Hydroxychloroquine — full drug profile →
• Leflunomide-Sulfasalazine-Hydroxychloroquine — full drug profile →

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

University of Nebraska

Who can join

Adults 19 to 80, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Measuring the Safety and Efficacy of a New DMARD, Leflunomide Alone or in Combination With Traditional DMARD's. Participants Reaching ACR 20 Response. at 48 Weeks Primary · 48 weeks

The combination of Methotrexate-Sulfasalazine-Hydroxychloroquine has been shown to be more effective than Methotrexate alone or the double combination of Methotrexate-Hydroxychloroquine. Primary outcome is ACR 20 response at 48 weeks. An ACR 20 Response is a measure of at least 20% improvement in the number of tender and swollen joints. and a 20% improvement in at least 3 of the following: the patient's global assessment of disease status; the patient's assessment of pain; the patient's assessment of function; the physician's global assessment of disease status; serum C-reactive protein leve

Group	Value	95% CI
1 Leflunomide Alone vs Combination Therapy	8
Methotrexate-Sulfasalazine-Hydroxychloroquine	20
Leflunomide-Sulfasalazine-Hydroxychloroquine	12

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

1 Leflunomide Alone vs Combination Therapy

Serious: 1/22 (5%)

Deaths: —

Methotrexate-Sulfasalazine-Hydroxychloroquine

Serious: 0/23 (0%)

Deaths: —

Leflunomide-Sulfasalazine-Hydroxychloroquine

Serious: 0/24 (0%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	1 Leflunomide Alone vs Com…	Methotrexate-Sulfasalazine…	Leflunomide-Sulfasalazine-…
lung carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	1 Leflunomide Alone vs Com…	Methotrexate-Sulfasalazine…	Leflunomide-Sulfasalazine-…
GI distress	Gastrointestinal disorders	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—
Depression	Psychiatric disorders	—	—	—
Elevated liver enzymes	Hepatobiliary disorders	—	—	—
Keratitis	Skin and subcutaneous tissue disorders	—	—	—

Most-reported serious reactions: lung carcinoma.

Data from ClinicalTrials.gov NCT00579878 adverse events section.

Sponsor's own description

The study has been designed as a 48-week, double-blind, randomized, controlled study comparing the use of leflunomide alone to combinations of leflunomide-sulfasalazine-HCQ, and methotrexate-sulfasalazine-HCQ.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.