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A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis

Primary Purpose

Lupus Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Laquinimod
Placebo
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Arthritis focused on measuring Systemic Lupus Erythematosus (SLE), Lupus Arthritis, Laquinimod

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Teva Investigational Site 1363
  • Teva Investigational Site 1368
  • Teva Investigational Site 1359
  • Teva Investigational Site 1352
  • Teva Investigational Site 1365
  • Teva Investigational Site 1357
  • Teva Investigational Site 1367
  • Teva Investigational Site 1370
  • Teva Investigational Site 1362
  • Teva Investigational Site 1360
  • Teva Investigational Site 1369
  • Teva Investigational Site 1353
  • Teva Investigational Site 1355
  • Teva Investigational Site 1356
  • Teva Investigational Site 1354
  • Teva Investigational Site 1366
  • Teva Investigational Site 1139
  • Teva Investigational Site 1141
  • Teva Investigational Site 1138
  • Teva Investigational Site 1136
  • Teva Investigational Site 1137
  • Teva Investigational Site 1142

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Laquinimod 0.5 mg

Laquinimod 1 mg

Arm Description

Participants will receive 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks.

Participants will receive 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks.

Participants will receive 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Percent Change From Baseline in Swollen Joint Count at Week 12
The number of swollen joints was used to assess lupus arthritis activity. Joint swelling was defined as soft tissue swelling that was detectable along the joint margins. 66 joints were examined for swelling. These joints include the temporomandibular (n = 2), sternoclavicular (n =2), acromioclavicular (n = 2), shoulder (n = 2), elbow (n = 2), wrist (n = 2), metacarpophalageal (n= 10), interphalangeal of thumb (n = 2), distal interphalangeal (n = 8), proximal interphalangeal (n =8), knee (n = 2), ankle mortise (n = 2), ankle tarsus (n = 2), metatarsophalangeal (n = 10), interphalangeal of great toe (n = 2), and proximal/distal interphalangeal of the toes (n = 8).
Percent Change From Baseline in Tender Joint Count at Week 12
The number of tender joints was used to assess lupus arthritis activity. Joint tenderness was defined as the presence or absence of tenderness and/or pain in a joint at rest with pressure or on passive movement of the joint and joint manipulation. 68 joints were examined for tenderness. These joints include the temporomandibular (n = 2), sternoclavicular (n =2), acromioclavicular (n = 2), shoulder (n = 2), elbow (n = 2), wrist (n = 2), metacarpophalageal (n= 10), interphalangeal of thumb (n = 2), distal interphalangeal (n = 8), proximal interphalangeal (n =8), hip (n = 2), knee (n = 2), ankle mortise (n = 2), ankle tarsus (n = 2), metatarsophalangeal (n = 10), interphalangeal of great toe (n = 2), and proximal/distal interphalangeal of the toes (n = 8).

Secondary Outcome Measures

Full Information

First Posted
March 9, 2010
Last Updated
June 9, 2022
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01085084
Brief Title
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis
Official Title
A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Systemic Lupus Erythematosus Patients With Active Lupus Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 4, 2010 (Actual)
Primary Completion Date
November 12, 2012 (Actual)
Study Completion Date
November 12, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Arthritis
Keywords
Systemic Lupus Erythematosus (SLE), Lupus Arthritis, Laquinimod

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks.
Arm Title
Laquinimod 0.5 mg
Arm Type
Experimental
Arm Description
Participants will receive 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks.
Arm Title
Laquinimod 1 mg
Arm Type
Experimental
Arm Description
Participants will receive 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Laquinimod
Intervention Description
Laquinimod will be administered per dose and schedule specified in the arm description.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to laquinimod will be administered per schedule specified in the arm description.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Time Frame
Baseline up to Week 16
Title
Percent Change From Baseline in Swollen Joint Count at Week 12
Description
The number of swollen joints was used to assess lupus arthritis activity. Joint swelling was defined as soft tissue swelling that was detectable along the joint margins. 66 joints were examined for swelling. These joints include the temporomandibular (n = 2), sternoclavicular (n =2), acromioclavicular (n = 2), shoulder (n = 2), elbow (n = 2), wrist (n = 2), metacarpophalageal (n= 10), interphalangeal of thumb (n = 2), distal interphalangeal (n = 8), proximal interphalangeal (n =8), knee (n = 2), ankle mortise (n = 2), ankle tarsus (n = 2), metatarsophalangeal (n = 10), interphalangeal of great toe (n = 2), and proximal/distal interphalangeal of the toes (n = 8).
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in Tender Joint Count at Week 12
Description
The number of tender joints was used to assess lupus arthritis activity. Joint tenderness was defined as the presence or absence of tenderness and/or pain in a joint at rest with pressure or on passive movement of the joint and joint manipulation. 68 joints were examined for tenderness. These joints include the temporomandibular (n = 2), sternoclavicular (n =2), acromioclavicular (n = 2), shoulder (n = 2), elbow (n = 2), wrist (n = 2), metacarpophalageal (n= 10), interphalangeal of thumb (n = 2), distal interphalangeal (n = 8), proximal interphalangeal (n =8), hip (n = 2), knee (n = 2), ankle mortise (n = 2), ankle tarsus (n = 2), metatarsophalangeal (n = 10), interphalangeal of great toe (n = 2), and proximal/distal interphalangeal of the toes (n = 8).
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, M.D.
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 1363
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Teva Investigational Site 1368
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Teva Investigational Site 1359
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7077
Country
United States
Facility Name
Teva Investigational Site 1352
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0792
Country
United States
Facility Name
Teva Investigational Site 1365
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Teva Investigational Site 1357
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Teva Investigational Site 1367
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Teva Investigational Site 1370
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Teva Investigational Site 1362
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Teva Investigational Site 1360
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Teva Investigational Site 1369
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Teva Investigational Site 1353
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Teva Investigational Site 1355
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Teva Investigational Site 1356
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Teva Investigational Site 1354
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Teva Investigational Site 1366
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Teva Investigational Site 1139
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Teva Investigational Site 1141
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L7
Country
Canada
Facility Name
Teva Investigational Site 1138
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M4
Country
Canada
Facility Name
Teva Investigational Site 1136
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Teva Investigational Site 1137
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Teva Investigational Site 1142
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis

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