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This is a Phase I clinical trial to determine whether orally administered APL A12 at one or more doses is superior to placebo in effecting a 25% reduction in interferon (IFN) stimulation index in 1(II)-stimulated culture of peripheral blood mononuclear (PBMC) obtained from patients with Rheumatoid Arthritis (RA), which will be the primary outcome variable. In an effort to learn more about the mechanism of action of APL A12, the investigators will assess Th1/Th2/Th3 cytokine production in supernatants from 48h and 144h cultures of PBMC stimulated by 1(II) and by APL A12 above. The investigators will assess function of CD4+ CD25+ T regs to determine whether APL A12 improves their suppressive function. Flow cytometry combined with intracellular cytokine staining will be used in an effort to determine which T cell subset(s) is/are experiencing shifts in cytokine expression.
The study will have 3 treatment arms each with 10 patients who have demonstrated T cell immunity to CII and have an in vitro response to APL A12 at the screening visit. Patients will be randomized to one of the 3 treatment arms. Each of the 3 treatments will be given for 16 weeks.
In keeping with a sequential dose escalation strategy, the originally proposed randomization scheme will be modified so that subjects will be randomized to receive either the lowest dose (30 mg) or placebo (Block 1), followed by the next dose (50 mg) or placebo (Block 2). We will begin with the lowest dose (30 g/day) and enroll 6 to receive 30 g/day APL A12 and 2 to receive placebo for 16 weeks. Results will be reported to the Data Monitoring Committee (DMC) for a decision to proceed to the next block based on indications of safety. If this dose does not cause adverse events or toxicity or worsens RA, we will proceed to enroll patients to receive 30 ug, or 50 g/day APL A12 or placebo for 16 weeks. A total of 32 subjects will be randomized to obtain 24 subjects who complete the study. Recruitment was difficult. Only 22 patients were randomized. There were not enough 50mcg patients enrolled so 2 treatment groups was analyzed. Arm 1 included 30 and 50 mcg and Arm 2 represents the patients that received placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | The study will have 3 treatment arms each with 10-12 patients who have demonstrated T cell immunity to CII and have an in vitro response to APL A12 at the screening visit. Patients will be randomized to one of the 2 treatment arms (30 micrograms APL A12 or placebo). Each of the 2 treatments will be given for 16 weeks. Intervention: Drug treatment will be stopped or interrupted if indicated and medical care will be given as appropriate. Intervention: Drug treatment will be stopped or interrupted if indicated and medical care will be given as appropriate. |
|
| Arm 2 | Experimental | The next group will receive a higher dose (50 micrograms) and/or placebo (Block 2). Intervention: Drug treatment will be stopped or interrupted if indicated and medical care will be given as appropriate. |
|
| Arm 3 | Experimental | Block 3 (Arm 3) will include placebo and both doses of APL/A12 to ensure 10-12 patients are enrolled in each arm ( total of approximately 32 subjects) so we will have 24 subjects who complete the 16 weeks of study treatment. Arms 2 and 3 will run simultaneously. Intervention: Drug treatment will be stopped or interrupted if indicated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APLA12 | Drug | Intervention: Drug treatment will be stopped or interrupted if indicated. Medical care will be provided at no cost to the patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percent of Participants With Reduction of Immunity to Collagen Type-II After APLA-12 Treatment. | The primary outcome variable is the presence of a > 25% reduction in net IFN concentration in supernatants of 1(II)-stimulated PBMC cultures from baseline after 16 weeks of treatment. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Flow Cytometry | Change in Percentage of CD4+CD25+FoxP3 T regulatory cells, CD4+IL-10+ cells, CD4+ IL-4+ cells, CD4+IL17+ cells. Some patients had only had enough blood collected at 8 weeks or 16 weeks or dropped out after 8 weeks, and we used/combined what was available. | baseline and 8 or 16 weeks |
| Clinical Disease Activity Index (CDAI) at 0 and 16 Weeks Follow up |
Not provided
Inclusion Criteria:
Patients must meet the following criteria for participation in the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnold E Postlethwaite, MD | Memphis VA Medical Center, Memphis, TN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memphis VA Medical Center, Memphis, TN | Memphis | Tennessee | 38104 | United States |
Not provided
October 1, 2009-September 30, 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | 30 mcg of APL/Day | 30 micrograms compared with placebo |
| FG001 | 50 ug APL/Day | 50 mcg and 30mcg compared to placebo |
| FG002 | Placebo | Placebo group |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients with rheumatoid arthritis who had an immunity demonstrated to type II collagen who were unable to be reduced in in vitro culture by APL A12.
30 and 50 mcg/day doses were combined because animal data showed no difference between doses.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 30 or 50 ug APL/Day | The study will have 3 treatment arms each with 10-12 patients who have demonstrated T cell immunity to CII and have an in vitro response to APL A12 at the screening visit. Patients will be randomized to one of the 3 treatment arms. Each of the 3 treatments will be given for 16 weeks. In keeping with a sequential dose escalation strategy, the originally proposed randomization scheme will be modified so that subjects will be randomized to receive: either the lowest dose (30 micrograms) or placebo (Block 1). We will begin with the lowest dose (30 micrograms/day) and enroll 6 to receive 30 micrograms/day APL A12 and 2 to receive placebo for 16 weeks. Results will be reported to the DMC for a decision to proceed to the next block based on indications of safety APL A12: IND 103860: The study drug APL A12 is a man made (or synthesized) fragment similar to a portion of natural type II collagen, the major collagen found in joint cartilage. Cartilage is the tough, elastic tissue found in |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 and Percent of Participants With Reduction of Immunity to Collagen Type-II After APLA-12 Treatment. | The primary outcome variable is the presence of a > 25% reduction in net IFN concentration in supernatants of 1(II)-stimulated PBMC cultures from baseline after 16 weeks of treatment. | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Count of Participants | Participants | 16 weeks |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 30 ug and 50 ug APL/Day | 30 micrograms APL A12/day and 50 micrograms APL A12/day APL A12: IND 103860: The study drug APL A12 is a man made (or synthesized) fragment similar to a portion of natural type II collagen, the major collagen found in joint cartilage. Cartilage is the tough, elastic tissue found in various parts of the body, including the joints. The best dose of APL A12 to use in patients with rheumatoid arthritis is not known. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac arrest | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| malaise, itching | Immune system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arnold E. Postlethwaite,MD Principal Investigator | Memphis VAMC | 901 448 5774 | apostlet@uthsc.edu |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Placebo | Drug | Drug treatment will be stopped or interrupted if indicated. Medical care will be provided at no cost to the patient. |
|
Interpretation of Clinical Disease Activity Index (CDAI) scores < 2.8 indicate remission; >2.8 and <= 10 indicates low disease activity; >10 and <= 22 indicates moderate disease activity; >22 indicates high disease activity. |
| 0 and16 weeks |
| Change in Cytokine Profile From Baseline and 16 Weeks | Cytokines assessed are IL-10, IL-13, IL-5, IL-1B, IL-9, IL-17A, IL-6, IL-21, TGF-B, TNFa,and MIP3A. | 0 and 16 weeks |
| Change in IgG and IgA Immunoglobulin From Baseline to 8 or 16 Weeks | The change was computed between baseline and 8 or 16 weeks, whichever was available. | baseline and 8 or 16 wks |
| Neutrophils Counts at 0 and 16 Weeks | Laboratory Results of A12 vs Placebo:Complete blood count Neutrophil count to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | Baseline and 16 weeks |
| A12 Treated vs Placebo of Monocytes. | Laboratory Results of A12 treated vs Placebo of Monocytes to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | Baseline and 16 wks |
| Eosinophils | Laboratory Results of A12 treated vs Placebo of Eosinophils to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | Baseline and 16 weeks |
| Laboratory Results of A12 vs Placebo: Lymphocytes | Measure to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | 0-16 weeks |
| Laboratory Results of A12 vs Placebo: Basophils | Measure to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | Baseline and 16 weeks |
| Hematocrit | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | 0-16 weeks |
| Laboratory Results of A12 vs Placebo-Total Immunoglobulin (Immature Granulocytes) | Measure to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | Baseline and 16 weeks |
| Red Blood Cell Distribution Width (RDW) | Laboratory Results of A12 vs Placebo RDW is a measure of the range of variation of red blood cell volume reported as part of a standard blood count to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | 0 and 16 weeks |
| Hemaglobin | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | Baseline and 16 weeks |
| Red Blood Cells | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | 0-16 weeks |
| White Blood Count | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | 0-16 weeks |
| Platelets | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | 0-16 weeks |
| AST, ALT and Alkaline Phosphatase | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | 0-16 weeks |
| Ca, BUN, Glucose,Creatinine, Total Bilirubin | Laboratory Results of A12 vs Placebo-CMP to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | 0-16 weeks |
| Sodium, Potassium and Chloride | Laboratory results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | 0-16 weeks |
| Total Protein, Albumin | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | 0-16 weeks |
| C-reactive Protein | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | 0-16 weeks |
| Rheumatoid Factor | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | 0-16 weeks |
| Sedimentation Rate | Laboratory results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | 0-16 weeks |
| Laboratory Results of A12 vs Placebo Anti-CCP Antibody | 0-16 weeks |
| Patient Global Assessment (PGA) and Physician Global Assessment | Patient and Physician (PI) Assessments both range from 0-10 with 10 being the most disease activity | 0-16 weeks |
| Modified Health Assessment Questionnaire (MHAQ) | Modified Health Assessment Questionnaire (MHAQ) 0-8 with 8 being the most activity | 0-16 weeks |
| Duration of Morning Stiffness in Joints | Duration of morning stiffness in the joints, in minutes. | 0-16 weeks |
| CDAI | Clinical Disease Activity Index (CDAI) 0-76 mm. Interpretation of CDAI scores < 2.8 indicate remission; >2.8 and <= 10 indicates low disease activity; >10 and <= 22 indicates moderate disease activity; >22 indicates high disease activity. | 0-16 weeks |
| Vital Signs-Temperature | 0-16 weeks |
| Vital Sign - Pulse | heartbeats per minute | 0-16 weeks |
| Weight | Weight in kg | 0-16 weeks |
| Vitals - Blood Pressure | measurement of blood pressure (mmHg) | 0 weeks and 16 weeks |
| Vitals - Respirations | Respirations represents breaths per minute | 0 weeks and 16 weeks |
| began prohibitive drug |
|
| BG001 | Placebo | Block 3 (Arm 3) will include placebo and both doses of APL/A12 to ensure 10-12 patients are enrolled in each arm ( total of approximately 32 subjects) so we will have 24 subjects who complete the 16 weeks of study treatment. Arms 2 and 3 will run simultaneously. APL A12: IND 103860: The study drug APL A12 is a man made (or synthesized) fragment similar to a portion of natural type II collagen, the major collagen found in joint cartilage. Cartilage is the tough, elastic tissue found in various parts of the body, including the joints. The best dose of APL A12 to use in patients with rheumatoid arthritis is not known. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | All southern region residents | Count of Participants | Participants |
|
| Immunity to Type-II collagen and in vitro decrease by APL12 | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements. | Count of Participants | Participants |
|
| OG001 | Placebo | Block 3 (Arm 3) will include placebo. Dose of placebo was 2ml of IV saline. |
|
|
|
| Secondary | Flow Cytometry | Change in Percentage of CD4+CD25+FoxP3 T regulatory cells, CD4+IL-10+ cells, CD4+ IL-4+ cells, CD4+IL17+ cells. Some patients had only had enough blood collected at 8 weeks or 16 weeks or dropped out after 8 weeks, and we used/combined what was available. | Not all participants had data available for all measurements. | Posted | Mean | Standard Deviation | percent change in number of cells | baseline and 8 or 16 weeks |
|
|
|
| Secondary | Clinical Disease Activity Index (CDAI) at 0 and 16 Weeks Follow up | Interpretation of Clinical Disease Activity Index (CDAI) scores < 2.8 indicate remission; >2.8 and <= 10 indicates low disease activity; >10 and <= 22 indicates moderate disease activity; >22 indicates high disease activity. | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Full Range | disease activity score | 0 and16 weeks |
|
|
|
|
| Secondary | Change in Cytokine Profile From Baseline and 16 Weeks | Cytokines assessed are IL-10, IL-13, IL-5, IL-1B, IL-9, IL-17A, IL-6, IL-21, TGF-B, TNFa,and MIP3A. | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Deviation | absolute change (picograms/milliliter) | 0 and 16 weeks |
|
|
|
|
| Secondary | Change in IgG and IgA Immunoglobulin From Baseline to 8 or 16 Weeks | The change was computed between baseline and 8 or 16 weeks, whichever was available. | Some participants only had measurable data at 8 weeks, or dropped out before 16 weeks. | Posted | Mean | Standard Deviation | absolute change (followup-baseline) ng/m | baseline and 8 or 16 wks |
|
|
|
| Secondary | Neutrophils Counts at 0 and 16 Weeks | Laboratory Results of A12 vs Placebo:Complete blood count Neutrophil count to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | percent of total number of blood cells | Baseline and 16 weeks |
|
|
|
| Secondary | A12 Treated vs Placebo of Monocytes. | Laboratory Results of A12 treated vs Placebo of Monocytes to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | percent of total white blood cells | Baseline and 16 wks |
|
|
|
| Secondary | Eosinophils | Laboratory Results of A12 treated vs Placebo of Eosinophils to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | percent in total white blood cells | Baseline and 16 weeks |
|
|
|
| Secondary | Laboratory Results of A12 vs Placebo: Lymphocytes | Measure to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | percent in total white blood cells/ml | 0-16 weeks |
|
|
|
| Secondary | Laboratory Results of A12 vs Placebo: Basophils | Measure to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | percent in total white blood cells/ml | Baseline and 16 weeks |
|
|
|
| Secondary | Hematocrit | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | ratio of RBC to total blood cells/volume | 0-16 weeks |
|
|
|
| Secondary | Laboratory Results of A12 vs Placebo-Total Immunoglobulin (Immature Granulocytes) | Measure to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | grams per deciliter | Baseline and 16 weeks |
|
|
|
| Secondary | Red Blood Cell Distribution Width (RDW) | Laboratory Results of A12 vs Placebo RDW is a measure of the range of variation of red blood cell volume reported as part of a standard blood count to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | percent of mean corpuscular volume | 0 and 16 weeks |
|
|
|
| Secondary | Hemaglobin | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | grams/deciliter | Baseline and 16 weeks |
|
|
|
| Secondary | Red Blood Cells | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | 10^6 cells/uL | 0-16 weeks |
|
|
|
| Secondary | White Blood Count | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | 10^3 cells/uL | 0-16 weeks |
|
|
|
| Secondary | Platelets | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | 10^3 cells/uL | 0-16 weeks |
|
|
|
| Secondary | AST, ALT and Alkaline Phosphatase | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | IU/L | 0-16 weeks |
|
|
|
| Secondary | Ca, BUN, Glucose,Creatinine, Total Bilirubin | Laboratory Results of A12 vs Placebo-CMP to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | mg/dl | 0-16 weeks |
|
|
|
| Secondary | Sodium, Potassium and Chloride | Laboratory results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | mmol/L | 0-16 weeks |
|
|
|
| Secondary | Total Protein, Albumin | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | g/dL | 0-16 weeks |
|
|
|
| Secondary | C-reactive Protein | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | mg/L | 0-16 weeks |
|
|
|
| Secondary | Rheumatoid Factor | Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | IU/mL | 0-16 weeks |
|
|
|
| Secondary | Sedimentation Rate | Laboratory results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | mm/hr | 0-16 weeks |
|
|
|
| Secondary | Laboratory Results of A12 vs Placebo Anti-CCP Antibody | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | IU/mL | 0-16 weeks |
|
|
|
| Secondary | Patient Global Assessment (PGA) and Physician Global Assessment | Patient and Physician (PI) Assessments both range from 0-10 with 10 being the most disease activity | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | score on a scale | 0-16 weeks |
|
|
|
| Secondary | Modified Health Assessment Questionnaire (MHAQ) | Modified Health Assessment Questionnaire (MHAQ) 0-8 with 8 being the most activity | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | MHAQ units on a scale | 0-16 weeks |
|
|
|
| Secondary | Duration of Morning Stiffness in Joints | Duration of morning stiffness in the joints, in minutes. | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | minutes | 0-16 weeks |
|
|
|
| Secondary | CDAI | Clinical Disease Activity Index (CDAI) 0-76 mm. Interpretation of CDAI scores < 2.8 indicate remission; >2.8 and <= 10 indicates low disease activity; >10 and <= 22 indicates moderate disease activity; >22 indicates high disease activity. | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | centimeters | 0-16 weeks |
|
|
|
| Secondary | Vital Signs-Temperature | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | degrees Fahrenheit | 0-16 weeks |
|
|
|
| Secondary | Vital Sign - Pulse | heartbeats per minute | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | beats per minute | 0-16 weeks |
|
|
|
| Secondary | Weight | Weight in kg | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | kilograms | 0-16 weeks |
|
|
|
| Secondary | Vitals - Blood Pressure | measurement of blood pressure (mmHg) | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | mm Hg | 0 weeks and 16 weeks |
|
|
|
| Secondary | Vitals - Respirations | Respirations represents breaths per minute | We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements | Posted | Mean | Standard Error | breaths per minute | 0 weeks and 16 weeks |
|
|
|
| 1 |
| 14 |
| 2 |
| 14 |
| 8 |
| 14 |
| EG001 | Placebo | Block 3 (Arm 3) will include placebo Dose was 2ml of IV saline. | 0 | 8 | 0 | 8 | 6 | 8 |
| pancreatitis | Gastrointestinal disorders | Systematic Assessment | hospitalized |
|
| flu-GI virus | Immune system disorders | Systematic Assessment |
|
| RA flare | Immune system disorders | Systematic Assessment |
|
| Burning rash on cheek | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| lips tingling | Nervous system disorders | Systematic Assessment |
|
| lightheaded with ringing in ears | General disorders | Systematic Assessment |
|
| injection site infection | Infections and infestations | Non-systematic Assessment |
|
| sprained ankle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| pet bite | Infections and infestations | Non-systematic Assessment |
|
| l4-l5 decompression | Surgical and medical procedures | Non-systematic Assessment |
|
| broken tooth | General disorders | Non-systematic Assessment |
|
| lesion removed from ear | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| inguinal hernia repair | Surgical and medical procedures | Non-systematic Assessment |
|
| sinusitis | General disorders | Non-systematic Assessment |
|
| atypical chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| sore throat | General disorders | Non-systematic Assessment |
|
| bursitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| lipoma removal | Surgical and medical procedures | Non-systematic Assessment |
|
| DJD worse | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| CD4+CD25hi+FoxP3 |
|
|
| CD4+IL-17+ |
|
|
| CD4+IL-10+ |
|
|
| CDAI at 16 weeks |
|
|
| IL-5 |
|
| IL-1B |
|
| IL-9 |
|
| TGF-B1 |
|
| IL-17A |
|
| IL-6 |
|
| TNFa |
|
| IL-21 |
|
| MIP3A(CCL-20) |
|
| 0 week ALT |
|
| 16 week ALT |
|
| 0 week alkaline phos |
|
| 16 week alkaline phos |
|
| 0 week BUN |
|
| 16 week BUN |
|
| 0 week glucose |
|
| 16 week glucose |
|
| 0 week total bilirubin |
|
| 16 week total bilirubin |
|
| 0 week creatinine |
|
| 16 week creatinine |
|
| 0 week potassium |
|
| 16 week potassium |
|
| 0 week chloride |
|
| 16 week chloride |
|
| 0 week albumin |
|
| 16 week albumin |
|
| 0 week Patient Assessment |
|
| 16 week Patient Assessment |
|
| 0 week diastolic |
|
| 16 week diastolic |
|