Lupus ArthritisPhase 2NCT01085084

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

A Phase 2 study testing Laquinimod in people with Lupus Arthritis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 22 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Lupus Arthritis
What is being tested?: Laquinimod
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 82 participants
Where: 22 sitesin 2 countries
Study dates: 4 Oct 2010to 12 Nov 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

22 sites in 2 countries.

Country

City, postcode or hospital

22 sites in 2 countries

United States16 sites

Teva Investigational Site 1370
Baltimore, Maryland, 21205
Teva Investigational Site 1363
Birmingham, Alabama, 35216
Teva Investigational Site 1366
Charleston, South Carolina, 29425
Teva Investigational Site 1356
Charlotte, North Carolina, 28210
Teva Investigational Site 1367
Chicago, Illinois, 60637
Teva Investigational Site 1354
Columbus, Ohio, 43210
Teva Investigational Site 1362
Cumberland, Maryland, 21502
Teva Investigational Site 1360
Hagerstown, Maryland, 21740
Teva Investigational Site 1368
Los Angeles, California, 90048
Teva Investigational Site 1359
Los Angeles, California, 90095-7077
Teva Investigational Site 1353
Manhasset, New York, 11030
Teva Investigational Site 1355
New York, New York, 10016
Teva Investigational Site 1352
San Francisco, California, 94143-0792
Teva Investigational Site 1365
San Leandro, California, 94578
Teva Investigational Site 1357
Stanford, California, 94305
Teva Investigational Site 1369
The Bronx, New York, 10467

Other trials in United States

Canada6 sites

Teva Investigational Site 1139
Edmonton, Alberta, T6G 2B7
Teva Investigational Site 1136
London, Ontario, N6A 4V2
Teva Investigational Site 1142
Montreal, Quebec, H3G 1A4
Teva Investigational Site 1137
Toronto, Ontario, M5T 2S8
Teva Investigational Site 1141
Vancouver, British Columbia, V5Z 1L7
Teva Investigational Site 1138
Winnipeg, Manitoba, R3A 1M4

Other trials in Canada

About this study

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

Conditions: Lupus Arthritis
Being tested: Laquinimod, Placebo
Keywords: Systemic Lupus Erythematosus (SLE), Lupus Arthritis, Laquinimod
Medical subject headings: Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LaquinimodDrug
Laquinimod will be administered per dose and schedule specified in the arm description.
PlaceboDrug
Placebo matching to laquinimod will be administered per schedule specified in the arm description.

Study groups in NCT01085084
Study group	Role	What they receive
Placebo	Placebo comparator	Participants will receive 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks. Receives: Drug: Placebo
Laquinimod 0.5 mg	Experimental	Participants will receive 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks. Receives: Drug: Laquinimod; Drug: Placebo
Laquinimod 1 mg	Experimental	Participants will receive 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks. Receives: Drug: Laquinimod

What is being measured

The primary outcome is the main question the study is designed to answer.

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'.
Measured: Baseline up to Week 16
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).
Measured: Baseline, Week 12
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).
Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 201012 Nov 2012

First posted11 Mar 2010 (estimated)
Study start4 Oct 2010
Primary completion12 Nov 2012
Study completion12 Nov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lupus ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01085084
Sponsor's protocol ID: LA-LAQ-202
Status last verified: Jun 2022
First submitted: 9 Mar 2010
Last updated: 7 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lupus Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01085084
Acronym / sponsor ID: LA-LAQ-202
Conditions: Lupus Arthritis
Keywords: Systemic Lupus Erythematosus (SLE), Lupus Arthritis, Laquinimod
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
Study start: 4 Oct 2010 (actual)
Primary completion: 12 Nov 2012 (actual)
Study completion: 12 Nov 2012 (actual)
First posted: 11 Mar 2010 (estimated)
Results: Posted 7 Jul 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks.
Laquinimod 0.5 mg	Experimental	Drug: Laquinimod, Drug: PlaceboParticipants will receive 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks.
Laquinimod 1 mg	Experimental	Drug: LaquinimodParticipants will receive 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LaquinimodLaquinimod will be administered per dose and schedule specified in the arm description.	Drug	Laquinimod 0.5 mg, Laquinimod 1 mg
PlaceboPlacebo matching to laquinimod will be administered per schedule specified in the arm description.	Drug	Laquinimod 0.5 mg, Placebo

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to Week 16
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
Time frame: Baseline, 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
Time frame: Baseline, 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).

Results and safety

Results posted to the registry on 7 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	26	19
Laquinimod 0.5 mg	28	23
Laquinimod 1 mg	28	19

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: Baseline up to Week 16. Count of participants. Unit: Participants

Measure	Placebo n = 25	Laquinimod 0.5 mg n = 29	Laquinimod 1 mg n = 28
Value	21	29	25

Population analysed: Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.

Primary outcome: Percent Change From Baseline in Swollen Joint Count at Week 12

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: percent change

Measure	Placebo n = 26	Laquinimod 0.5 mg n = 27	Laquinimod 1 mg n = 26
Value	-36.9 (78.1)	-36.7 (47.0)	-40.5 (55.6)

Population analysed: Modified intent-to-treat (mITT) analysis set included all participants who were randomly assigned to a treatment, regardless of which treatment they actually received, excluding observations after treatment failure. Here 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Primary outcome: Percent Change From Baseline in Tender Joint Count at Week 12

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: percent change

Measure	Placebo n = 26	Laquinimod 0.5 mg n = 27	Laquinimod 1 mg n = 26
Value	-8.5 (81.3)	-31.4 (53.1)	-42.0 (37.8)

Population analysed: The mITT analysis set included all participants who were randomly assigned to a treatment, regardless of which treatment they actually received, excluding observations after treatment failure. Here 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Adverse events

Time frame: Baseline up to Week 16. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 25 (0%)	17 of 25 (68%)	0 of 25
Laquinimod 0.5 mg	4 of 29 (13.8%)	24 of 29 (82.8%)	0 of 29
Laquinimod 1 mg	2 of 28 (7.1%)	18 of 28 (64.3%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lupus Arthritis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Teva Medical Expert, M.D. study director

Teva Branded Pharmaceutical Products R&D, Inc.

22 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laquinimod in people with Lupus Arthritis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 22 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) (time frame: Baseline up to Week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01085084.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.