Phase 2
N=82
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis
Lupus Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01085084 ↗Enrolled (actual)
82
Serious AEs
7.3%
Results posted
Jul 2022
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) — 21; 29; 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Laquinimod (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
21; 29; 25 | — |
| PRIMARY Percent Change From Baseline in Swollen Joint Count at Week 12 |
-36.9; -36.7; -40.5 | — |
| PRIMARY Percent Change From Baseline in Tender Joint Count at Week 12 |
-8.5; -31.4; -42.0 | — |
Summary
The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules (0.5 milligrams [mg] and 1 mg) in participants with active lupus arthritis. Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.
Eligibility Criteria
Inclusion Criteria
- Participants diagnosed with SLE.
- Participants with active lupus arthritis as evident by at least 4 tender and 4 swollen joints at screening and baseline visits, and moderate or severe arthritis with active synovitis in at least 1 joint, with some loss of functional range of movement present at screening and baseline visits.
Exclusion Criteria
- The participant's estimated glomerular filtration rate (eGFR) was less than or equal to 30 milliliters (mL)/minute/1.73 square meter (m^2), as calculated by the Modification of Diet in Renal Disease (MDRD) formula at the screening visit.
- Participants with severe, unstable and/or progressive central nervous system (CNS) lupus and/or associated with significant cognitive impairment (upon the investigators' judgement).
- Participants with a clinically significant or unstable medical or surgical condition that, in the investigator's opinion, would preclude safe and complete study participation.
- Women who are pregnant or nursing or who intend to be during the study period.
- Women of child-bearing potential who do not practice an acceptable method of birth control.
Data sourced from ClinicalTrials.gov (NCT01085084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.