Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks. |
|
| 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. |
|
| Laquinimod 1 mg | Experimental | Participants will receive 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laquinimod | Drug | Laquinimod will be administered per dose and schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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'. | 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). | 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). |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, M.D. | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 1363 | Birmingham | Alabama | 35216 | United States | ||
| Teva Investigational Site 1368 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks. |
| FG001 | Laquinimod 0.5 mg | Participants received 1 capsule of laquinimod 0.5 milligrams (mg) and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo matching to laquinimod will be administered per schedule specified in the arm description. |
|
| Baseline, Week 12 |
| Los Angeles |
| California |
| 90048 |
| United States |
| Teva Investigational Site 1359 | Los Angeles | California | 90095-7077 | United States |
| Teva Investigational Site 1352 | San Francisco | California | 94143-0792 | United States |
| Teva Investigational Site 1365 | San Leandro | California | 94578 | United States |
| Teva Investigational Site 1357 | Stanford | California | 94305 | United States |
| Teva Investigational Site 1367 | Chicago | Illinois | 60637 | United States |
| Teva Investigational Site 1370 | Baltimore | Maryland | 21205 | United States |
| Teva Investigational Site 1362 | Cumberland | Maryland | 21502 | United States |
| Teva Investigational Site 1360 | Hagerstown | Maryland | 21740 | United States |
| Teva Investigational Site 1353 | Manhasset | New York | 11030 | United States |
| Teva Investigational Site 1355 | New York | New York | 10016 | United States |
| Teva Investigational Site 1369 | The Bronx | New York | 10467 | United States |
| Teva Investigational Site 1356 | Charlotte | North Carolina | 28210 | United States |
| Teva Investigational Site 1354 | Columbus | Ohio | 43210 | United States |
| Teva Investigational Site 1366 | Charleston | South Carolina | 29425 | United States |
| Teva Investigational Site 1139 | Edmonton | Alberta | T6G 2B7 | Canada |
| Teva Investigational Site 1141 | Vancouver | British Columbia | V5Z 1L7 | Canada |
| Teva Investigational Site 1138 | Winnipeg | Manitoba | R3A 1M4 | Canada |
| Teva Investigational Site 1136 | London | Ontario | N6A 4V2 | Canada |
| Teva Investigational Site 1137 | Toronto | Ontario | M5T 2S8 | Canada |
| Teva Investigational Site 1142 | Montreal | Quebec | H3G 1A4 | Canada |
| FG002 | Laquinimod 1 mg | Participants received 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks. |
| Received at Least 1 Dose of Study Drug |
|
| Safety Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-To-Treat (ITT) analysis set included all participants who were randomly assigned to a treatment, regardless of which treatment they actually received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks. |
| BG001 | Laquinimod 0.5 mg | Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks. |
| BG002 | Laquinimod 1 mg | Participants received 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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'. | 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. | Posted | Count of Participants | Participants | Baseline up to Week 16 |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | 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). | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||||
| Primary | 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). | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 12 |
|
Baseline up to Week 16
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks. | 0 | 25 | 0 | 25 | 17 | 25 |
| EG001 | Laquinimod 0.5 mg | Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks. | 0 | 29 | 4 | 29 | 24 | 29 |
| EG002 | Laquinimod 1 mg | Participants received 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks. | 0 | 28 | 2 | 28 | 18 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia Mycoplasmal | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal Tenderness | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Systemic Lupus Erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products R&D, Inc. | 1-888-483-8279 | USMedInfo@tevapharm.com |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C476223 | laquinimod |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| White |
|
| Hispanic |
|
| Native Hawaiian or Pacific Islander |
|
| Other |
|
| OG002 | Laquinimod 1 mg | Participants received 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks. |
|
|
| OG002 | Laquinimod 1 mg | Participants received 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks. |
|
|