Trial Outcomes & Findings for Phase 1 Trial of Type II Collagen (CII) APL A12 in Rheumatoid Arthritis Patients (NCT NCT01123655)
NCT ID: NCT01123655
Last Updated: 2019-03-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
16 weeks
Results posted on
2019-03-19
Participant Flow
October 1, 2009-September 30, 2015.
Participant milestones
| Measure |
30 mcg of APL/Day
30 micrograms compared with placebo
|
50 ug APL/Day
50 mcg and 30mcg compared to placebo
|
Placebo
Placebo group
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
4
|
8
|
|
Overall Study
COMPLETED
|
9
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
30 mcg of APL/Day
30 micrograms compared with placebo
|
50 ug APL/Day
50 mcg and 30mcg compared to placebo
|
Placebo
Placebo group
|
|---|---|---|---|
|
Overall Study
Medication for RA had to be changed
|
1
|
0
|
0
|
|
Overall Study
new illness
|
0
|
1
|
0
|
|
Overall Study
began prohibitive drug
|
0
|
0
|
1
|
Baseline Characteristics
Phase 1 Trial of Type II Collagen (CII) APL A12 in Rheumatoid Arthritis Patients
Baseline characteristics by cohort
| Measure |
30 or 50 ug APL/Day
n=14 Participants
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
|
Placebo
n=8 Participants
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.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Continuous
|
62.08 years
STANDARD_DEVIATION 8.47 • n=99 Participants
|
65.8 years
STANDARD_DEVIATION 9.91 • n=107 Participants
|
63.94 years
STANDARD_DEVIATION 8.88 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Immunity to Type-II collagen and in vitro decrease by APL12
|
12 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
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.
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=10 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=6 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Number and Percent of Participants With Reduction of Immunity to Collagen Type-II After APLA-12 Treatment.
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: baseline and 8 or 16 weeksPopulation: Not all participants had data available for all measurements.
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.
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Flow Cytometry
CD4+IL-4+
|
0.8959 percent change in number of cells
Standard Deviation 1.0736
|
1.9400 percent change in number of cells
Standard Deviation 2.8626
|
|
Flow Cytometry
CD4+CD25hi+FoxP3
|
3.4240 percent change in number of cells
Standard Deviation 4.3569
|
0.9600 percent change in number of cells
Standard Deviation 3.4390
|
|
Flow Cytometry
CD4+IL-17+
|
1.5299 percent change in number of cells
Standard Deviation 4.1486
|
-0.4230 percent change in number of cells
Standard Deviation 2.1367
|
|
Flow Cytometry
CD4+IL-10+
|
0.1735 percent change in number of cells
Standard Deviation 0.5400
|
0.3385 percent change in number of cells
Standard Deviation 0.4444
|
SECONDARY outcome
Timeframe: 0 and16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
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.
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=14 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=8 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Clinical Disease Activity Index (CDAI) at 0 and 16 Weeks Follow up
CDAI at 0 weeks
|
10.0333 disease activity score
Interval 0.7 to 12.5
|
10.3271 disease activity score
Interval 2.4 to 23.0
|
|
Clinical Disease Activity Index (CDAI) at 0 and 16 Weeks Follow up
CDAI at 16 weeks
|
9.8778 disease activity score
Interval 1.1 to 29.5
|
12.8000 disease activity score
Interval 6.7 to 19.5
|
SECONDARY outcome
Timeframe: 0 and 16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Cytokines assessed are IL-10, IL-13, IL-5, IL-1B, IL-9, IL-17A, IL-6, IL-21, TGF-B, TNFa,and MIP3A.
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Change in Cytokine Profile From Baseline and 16 Weeks
IL-10
|
-22.51 absolute change (picograms/milliliter)
Standard Deviation 82.57
|
-4.70 absolute change (picograms/milliliter)
Standard Deviation 5.99
|
|
Change in Cytokine Profile From Baseline and 16 Weeks
IL-13
|
-6.46 absolute change (picograms/milliliter)
Standard Deviation 17.12
|
-0.83 absolute change (picograms/milliliter)
Standard Deviation 4.57
|
|
Change in Cytokine Profile From Baseline and 16 Weeks
IL-5
|
5.19 absolute change (picograms/milliliter)
Standard Deviation 19.11
|
-2.42 absolute change (picograms/milliliter)
Standard Deviation 2.34
|
|
Change in Cytokine Profile From Baseline and 16 Weeks
IL-1B
|
617.1 absolute change (picograms/milliliter)
Standard Deviation 2111.8
|
45.64 absolute change (picograms/milliliter)
Standard Deviation 280.1
|
|
Change in Cytokine Profile From Baseline and 16 Weeks
IL-9
|
196.1 absolute change (picograms/milliliter)
Standard Deviation 679.2
|
-45.37 absolute change (picograms/milliliter)
Standard Deviation 56.10
|
|
Change in Cytokine Profile From Baseline and 16 Weeks
TGF-B1
|
0.12 absolute change (picograms/milliliter)
Standard Deviation 0.42
|
-0.06 absolute change (picograms/milliliter)
Standard Deviation 0.41
|
|
Change in Cytokine Profile From Baseline and 16 Weeks
IL-17A
|
-104.2 absolute change (picograms/milliliter)
Standard Deviation 229.9
|
5.4091 absolute change (picograms/milliliter)
Standard Deviation 7.4381
|
|
Change in Cytokine Profile From Baseline and 16 Weeks
IL-6
|
-2002.9 absolute change (picograms/milliliter)
Standard Deviation 10752.9
|
3.97 absolute change (picograms/milliliter)
Standard Deviation 261.4
|
|
Change in Cytokine Profile From Baseline and 16 Weeks
TNFa
|
-7.50 absolute change (picograms/milliliter)
Standard Deviation 39.98
|
0.30 absolute change (picograms/milliliter)
Standard Deviation 4.14
|
|
Change in Cytokine Profile From Baseline and 16 Weeks
IL-21
|
-4.32 absolute change (picograms/milliliter)
Standard Deviation 10.92
|
218.3 absolute change (picograms/milliliter)
Standard Deviation 492.9
|
|
Change in Cytokine Profile From Baseline and 16 Weeks
MIP3A(CCL-20)
|
-36.39 absolute change (picograms/milliliter)
Standard Deviation 89.60
|
3.60 absolute change (picograms/milliliter)
Standard Deviation 21.08
|
SECONDARY outcome
Timeframe: baseline and 8 or 16 wksPopulation: Some participants only had measurable data at 8 weeks, or dropped out before 16 weeks.
The change was computed between baseline and 8 or 16 weeks, whichever was available.
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=10 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=4 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Change in IgG and IgA Immunoglobulin From Baseline to 8 or 16 Weeks
change in IgG
|
1047.01 absolute change (followup-baseline) ng/m
Standard Deviation 3570.28
|
11.43 absolute change (followup-baseline) ng/m
Standard Deviation 109.27
|
|
Change in IgG and IgA Immunoglobulin From Baseline to 8 or 16 Weeks
change in IgA
|
3410.3 absolute change (followup-baseline) ng/m
Standard Deviation 11339.8
|
103.69 absolute change (followup-baseline) ng/m
Standard Deviation 233.92
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
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
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Neutrophils Counts at 0 and 16 Weeks
0 weeks Neutrophils
|
60.9 percent of total number of blood cells
Standard Error 2.4
|
60 percent of total number of blood cells
Standard Error 3.2
|
|
Neutrophils Counts at 0 and 16 Weeks
16 weeks Neutrophils
|
59.2 percent of total number of blood cells
Standard Error 2.6
|
62.4 percent of total number of blood cells
Standard Error 3.5
|
SECONDARY outcome
Timeframe: Baseline and 16 wksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
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
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
A12 Treated vs Placebo of Monocytes.
Baseline
|
9.1 percent of total white blood cells
Standard Error 0.7
|
9.25 percent of total white blood cells
Standard Error 0.9
|
|
A12 Treated vs Placebo of Monocytes.
16 weeks
|
8.93 percent of total white blood cells
Standard Error 0.7
|
7.53 percent of total white blood cells
Standard Error 1
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
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
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Eosinophils
Baseline
|
2.29 percent in total white blood cells
Standard Error 0.5
|
4.4 percent in total white blood cells
Standard Error 0.7
|
|
Eosinophils
16 weeks
|
2.69 percent in total white blood cells
Standard Error 0.6
|
4.11 percent in total white blood cells
Standard Error 0.7
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Measure to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Laboratory Results of A12 vs Placebo: Lymphocytes
0 Week Lymphocytes
|
26.92 percent in total white blood cells/ml
Standard Error 2.22
|
25.41 percent in total white blood cells/ml
Standard Error 2.94
|
|
Laboratory Results of A12 vs Placebo: Lymphocytes
16 weeks Lymphocytes
|
28.2 percent in total white blood cells/ml
Standard Error 2.35
|
25.37 percent in total white blood cells/ml
Standard Error 3.1
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Measure to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Laboratory Results of A12 vs Placebo: Basophils
0 week-Basophils
|
0.53 percent in total white blood cells/ml
Standard Error 0.09
|
0.6 percent in total white blood cells/ml
Standard Error 0.12
|
|
Laboratory Results of A12 vs Placebo: Basophils
16 week Basophils
|
0.67 percent in total white blood cells/ml
Standard Error 0.097
|
0.47 percent in total white blood cells/ml
Standard Error 0.13
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Hematocrit
0 week HCT
|
40.63 ratio of RBC to total blood cells/volume
Standard Error 0.85
|
42 ratio of RBC to total blood cells/volume
Standard Error 1.13
|
|
Hematocrit
16 week HCT
|
39.69 ratio of RBC to total blood cells/volume
Standard Error 0.9
|
42.6 ratio of RBC to total blood cells/volume
Standard Error 1.19
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Measure to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Laboratory Results of A12 vs Placebo-Total Immunoglobulin (Immature Granulocytes)
0 week-IG
|
0.3 grams per deciliter
Standard Error 0.05
|
0.24 grams per deciliter
Standard Error 0.06
|
|
Laboratory Results of A12 vs Placebo-Total Immunoglobulin (Immature Granulocytes)
16 week-IG
|
0.3 grams per deciliter
Standard Error 0.05
|
0.33 grams per deciliter
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 0 and 16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
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
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Red Blood Cell Distribution Width (RDW)
Baseline-RDW
|
14.67 percent of mean corpuscular volume
Standard Error 0.31
|
14.15 percent of mean corpuscular volume
Standard Error 0.41
|
|
Red Blood Cell Distribution Width (RDW)
16 week RDW
|
14.8 percent of mean corpuscular volume
Standard Error 0.33
|
13.9 percent of mean corpuscular volume
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Hemaglobin
Baseline -Hgb
|
13.66 grams/deciliter
Standard Error 0.29
|
14.23 grams/deciliter
Standard Error 0.38
|
|
Hemaglobin
16 week Hgb
|
13.31 grams/deciliter
Standard Error 0.3
|
14.31 grams/deciliter
Standard Error 0.4
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Red Blood Cells
0 week RBC
|
4.66 10^6 cells/uL
Standard Error 0.13
|
4.49 10^6 cells/uL
Standard Error 0.17
|
|
Red Blood Cells
16 week RBC
|
4.6 10^6 cells/uL
Standard Error 0.13
|
4.57 10^6 cells/uL
Standard Error 0.17
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
White Blood Count
0 week WBC
|
7.24 10^3 cells/uL
Standard Error 0.43
|
5.88 10^3 cells/uL
Standard Error 0.57
|
|
White Blood Count
16 week WBC
|
7.26 10^3 cells/uL
Standard Error 0.47
|
6.23 10^3 cells/uL
Standard Error 0.61
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Platelets
0 week Platelet
|
248.71 10^3 cells/uL
Standard Error 14.81
|
224.5 10^3 cells/uL
Standard Error 19.6
|
|
Platelets
16 week Platelet
|
256.96 10^3 cells/uL
Standard Error 15.51
|
225.44 10^3 cells/uL
Standard Error 20.43
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
AST, ALT and Alkaline Phosphatase
0 week-AST
|
32.29 IU/L
Standard Error 3.36
|
39.75 IU/L
Standard Error 3.97
|
|
AST, ALT and Alkaline Phosphatase
16 week AST
|
31.61 IU/L
Standard Error 3.67
|
33.52 IU/L
Standard Error 4.52
|
|
AST, ALT and Alkaline Phosphatase
0 week ALT
|
28.8 IU/L
Standard Error 3.2
|
35.75 IU/L
Standard Error 3.94
|
|
AST, ALT and Alkaline Phosphatase
16 week ALT
|
26.21 IU/L
Standard Error 3.33
|
35.62 IU/L
Standard Error 4.24
|
|
AST, ALT and Alkaline Phosphatase
0 week alkaline phos
|
97.79 IU/L
Standard Error 5.05
|
70.75 IU/L
Standard Error 6.13
|
|
AST, ALT and Alkaline Phosphatase
16 week alkaline phos
|
86.64 IU/L
Standard Error 5.34
|
73.07 IU/L
Standard Error 6.72
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
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
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Ca, BUN, Glucose,Creatinine, Total Bilirubin
0 week calcium
|
9.35 mg/dl
Standard Error 0.09
|
9.11 mg/dl
Standard Error 0.11
|
|
Ca, BUN, Glucose,Creatinine, Total Bilirubin
16 week calcium
|
9.2 mg/dl
Standard Error 0.1
|
9.22 mg/dl
Standard Error 0.12
|
|
Ca, BUN, Glucose,Creatinine, Total Bilirubin
0 week BUN
|
15.7 mg/dl
Standard Error 2.37
|
15.37 mg/dl
Standard Error 2.93
|
|
Ca, BUN, Glucose,Creatinine, Total Bilirubin
16 week BUN
|
17.32 mg/dl
Standard Error 2.45
|
15.56 mg/dl
Standard Error 3.13
|
|
Ca, BUN, Glucose,Creatinine, Total Bilirubin
0 week glucose
|
109.4 mg/dl
Standard Error 9.71
|
112.4 mg/dl
Standard Error 11.9
|
|
Ca, BUN, Glucose,Creatinine, Total Bilirubin
16 week glucose
|
92.67 mg/dl
Standard Error 10.2
|
86.72 mg/dl
Standard Error 12.9
|
|
Ca, BUN, Glucose,Creatinine, Total Bilirubin
0 week total bilirubin
|
0.68 mg/dl
Standard Error 0.067
|
0.63 mg/dl
Standard Error 0.082
|
|
Ca, BUN, Glucose,Creatinine, Total Bilirubin
16 week total bilirubin
|
0.53 mg/dl
Standard Error 0.7
|
0.75 mg/dl
Standard Error 0.088
|
|
Ca, BUN, Glucose,Creatinine, Total Bilirubin
0 week creatinine
|
0.945 mg/dl
Standard Error 0.208
|
0.811 mg/dl
Standard Error 0.244
|
|
Ca, BUN, Glucose,Creatinine, Total Bilirubin
16 week creatinine
|
1.0050 mg/dl
Standard Error 22.96
|
0.8501 mg/dl
Standard Error 0.2818
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Laboratory results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Sodium, Potassium and Chloride
0 week sodium
|
140.7 mmol/L
Standard Error 0.8
|
140.25 mmol/L
Standard Error 0.98
|
|
Sodium, Potassium and Chloride
16 week sodium
|
141.46 mmol/L
Standard Error 0.84
|
140.34 mmol/L
Standard Error 1.06
|
|
Sodium, Potassium and Chloride
0 week potassium
|
3.9 mmol/L
Standard Error 0.16
|
4 mmol/L
Standard Error 0.2
|
|
Sodium, Potassium and Chloride
16 week potassium
|
3.8 mmol/L
Standard Error 0.17
|
4.03 mmol/L
Standard Error 0.2
|
|
Sodium, Potassium and Chloride
0 week chloride
|
102.9 mmol/L
Standard Error 0.73
|
100.75 mmol/L
Standard Error 0.88
|
|
Sodium, Potassium and Chloride
16 week chloride
|
103.22 mmol/L
Standard Error 0.78
|
100.9 mmol/L
Standard Error 0.97
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Total Protein, Albumin
0 week total protein
|
7.75 g/dL
Standard Error 0.17
|
7.64 g/dL
Standard Error 0.2
|
|
Total Protein, Albumin
16 week total protein
|
7.16 g/dL
Standard Error 0.19
|
7.8 g/dL
Standard Error 0.2
|
|
Total Protein, Albumin
0 week albumin
|
4.18 g/dL
Standard Error 0.08
|
4.22 g/dL
Standard Error 0.098
|
|
Total Protein, Albumin
16 week albumin
|
4.16 g/dL
Standard Error 0.084
|
4.42 g/dL
Standard Error 0.11
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
C-reactive Protein
0 week CRP
|
11.8 mg/L
Standard Error 3.13
|
10.57 mg/L
Standard Error 4.61
|
|
C-reactive Protein
16 week CRP
|
11.38 mg/L
Standard Error 3.07
|
8 mg/L
Standard Error 4.61
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Rheumatoid Factor
0 week RF
|
36.72 IU/mL
Standard Error 9.4
|
23.75 IU/mL
Standard Error 14.15
|
|
Rheumatoid Factor
16 week RF
|
25.29 IU/mL
Standard Error 9.4
|
23.35 IU/mL
Standard Error 14.15
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Laboratory results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Sedimentation Rate
0 week ESR
|
30.85 mm/hr
Standard Error 5.13
|
18.62 mm/hr
Standard Error 6.7
|
|
Sedimentation Rate
16 week ESR
|
33.5 mm/hr
Standard Error 5.29
|
20.26 mm/hr
Standard Error 6.9
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Laboratory Results of A12 vs Placebo Anti-CCP Antibody
0 week anti CCP
|
310.6 IU/mL
Standard Error 35.2
|
127.54 IU/mL
Standard Error 44.9
|
|
Laboratory Results of A12 vs Placebo Anti-CCP Antibody
16 week anti CCP
|
319.07 IU/mL
Standard Error 35.63
|
120.9 IU/mL
Standard Error 45.52
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Patient and Physician (PI) Assessments both range from 0-10 with 10 being the most disease activity
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Patient Global Assessment (PGA) and Physician Global Assessment
0 week PI Assessment
|
2.6 score on a scale
Standard Error 0.46
|
3.26 score on a scale
Standard Error 0.77
|
|
Patient Global Assessment (PGA) and Physician Global Assessment
16 week PI Assessment
|
2.77 score on a scale
Standard Error 0.5
|
4.3 score on a scale
Standard Error 0.7
|
|
Patient Global Assessment (PGA) and Physician Global Assessment
0 week Patient Assessment
|
3.99 score on a scale
Standard Error 0.52
|
4.8 score on a scale
Standard Error 0.9
|
|
Patient Global Assessment (PGA) and Physician Global Assessment
16 week Patient Assessment
|
4.7 score on a scale
Standard Error 0.59
|
3.75 score on a scale
Standard Error 0.78
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Modified Health Assessment Questionnaire (MHAQ) 0-8 with 8 being the most activity
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Modified Health Assessment Questionnaire (MHAQ)
0 week MHAQ
|
3.44 MHAQ units on a scale
Standard Error 1.14
|
1.75 MHAQ units on a scale
Standard Error 1.71
|
|
Modified Health Assessment Questionnaire (MHAQ)
16 week MHAQ
|
4 MHAQ units on a scale
Standard Error 1.14
|
2.5 MHAQ units on a scale
Standard Error 1.9
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Duration of morning stiffness in the joints, in minutes.
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Duration of Morning Stiffness in Joints
0 week stiffness
|
64.49 minutes
Standard Error 98.81
|
38.75 minutes
Standard Error 140.22
|
|
Duration of Morning Stiffness in Joints
16 week stiffness
|
184.44 minutes
Standard Error 93.48
|
54.78 minutes
Standard Error 195.3
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
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.
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
CDAI
0 week CDAI
|
10 centimeters
Standard Error 2
|
10.3 centimeters
Standard Error 3.3
|
|
CDAI
16 week CDAI
|
9.9 centimeters
Standard Error 2.2
|
12.8 centimeters
Standard Error 3
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Vital Signs-Temperature
16 week temperature
|
97.4 degrees Fahrenheit
Standard Error 0.2
|
97.83 degrees Fahrenheit
Standard Error 0.27
|
|
Vital Signs-Temperature
0 week temperature
|
97.4 degrees Fahrenheit
Standard Error 0.19
|
98 degrees Fahrenheit
Standard Error 0.25
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
heartbeats per minute
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Vital Sign - Pulse
0 week pulse
|
73.8 beats per minute
Standard Error 3.23
|
72.46 beats per minute
Standard Error 4.34
|
|
Vital Sign - Pulse
16 week pulse
|
74.74 beats per minute
Standard Error 3.47
|
71.83 beats per minute
Standard Error 4.6
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Weight in kg
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Weight
0 week weight
|
84.06 kilograms
Standard Error 3.17
|
93.5 kilograms
Standard Error 4
|
|
Weight
16 week weight
|
83 kilograms
Standard Error 3.18
|
95.21 kilograms
Standard Error 4
|
SECONDARY outcome
Timeframe: 0 weeks and 16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
measurement of blood pressure (mmHg)
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Vitals - Blood Pressure
0 week BP systolic
|
134.85 mm Hg
Standard Error 3.9
|
131.51 mm Hg
Standard Error 5.2
|
|
Vitals - Blood Pressure
16 week BP systolic
|
130.35 mm Hg
Standard Error 4.2
|
140.67 mm Hg
Standard Error 5.5
|
|
Vitals - Blood Pressure
0 week diastolic
|
77.23 mm Hg
Standard Error 2.53
|
71.13 mm Hg
Standard Error 3.4
|
|
Vitals - Blood Pressure
16 week diastolic
|
76.9 mm Hg
Standard Error 2.74
|
74.75 mm Hg
Standard Error 3.67
|
SECONDARY outcome
Timeframe: 0 weeks and 16 weeksPopulation: We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements
Respirations represents breaths per minute
Outcome measures
| Measure |
APL 30 and 50ug/Day
n=12 Participants
30ug and 50ug/ day were combined for analysis and were combined because the period of funding expired before all the proposed number of patients could be enrolled for the 50ug/day Arm.
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 RA is not known.
|
Placebo
n=5 Participants
Block 3 (Arm 3) will include placebo.
Dose of placebo was 2ml of IV saline.
|
|---|---|---|
|
Vitals - Respirations
0 weeks
|
18.3 breaths per minute
Standard Error 0.63
|
18.84 breaths per minute
Standard Error 0.5
|
|
Vitals - Respirations
16 weeks
|
18.54 breaths per minute
Standard Error 0.4
|
17.7 breaths per minute
Standard Error 0.5
|
Adverse Events
30 ug and 50 ug APL/Day
Serious events: 2 serious events
Other events: 8 other events
Deaths: 1 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
30 ug and 50 ug APL/Day
n=14 participants at risk
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.
|
Placebo
n=8 participants at risk
Block 3 (Arm 3) will include placebo
Dose was 2ml of IV saline.
|
|---|---|---|
|
Cardiac disorders
cardiac arrest
|
7.1%
1/14 • Number of events 1 • 16 weeks
|
0.00%
0/8 • 16 weeks
|
|
Gastrointestinal disorders
pancreatitis
|
7.1%
1/14 • Number of events 1 • 16 weeks
|
0.00%
0/8 • 16 weeks
|
Other adverse events
| Measure |
30 ug and 50 ug APL/Day
n=14 participants at risk
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.
|
Placebo
n=8 participants at risk
Block 3 (Arm 3) will include placebo
Dose was 2ml of IV saline.
|
|---|---|---|
|
Immune system disorders
malaise, itching
|
7.1%
1/14 • Number of events 1 • 16 weeks
|
0.00%
0/8 • 16 weeks
|
|
Immune system disorders
flu-GI virus
|
14.3%
2/14 • Number of events 2 • 16 weeks
|
0.00%
0/8 • 16 weeks
|
|
Immune system disorders
RA flare
|
7.1%
1/14 • Number of events 1 • 16 weeks
|
0.00%
0/8 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Burning rash on cheek
|
7.1%
1/14 • Number of events 1 • 16 weeks
|
0.00%
0/8 • 16 weeks
|
|
Nervous system disorders
lips tingling
|
0.00%
0/14 • 16 weeks
|
12.5%
1/8 • Number of events 1 • 16 weeks
|
|
General disorders
lightheaded with ringing in ears
|
0.00%
0/14 • 16 weeks
|
12.5%
1/8 • Number of events 1 • 16 weeks
|
|
Infections and infestations
injection site infection
|
7.1%
1/14 • Number of events 1 • 16 weeks
|
0.00%
0/8 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
sprained ankle
|
7.1%
1/14 • Number of events 1 • 16 weeks
|
0.00%
0/8 • 16 weeks
|
|
Infections and infestations
pet bite
|
7.1%
1/14 • Number of events 1 • 16 weeks
|
0.00%
0/8 • 16 weeks
|
|
Surgical and medical procedures
l4-l5 decompression
|
7.1%
1/14 • Number of events 1 • 16 weeks
|
0.00%
0/8 • 16 weeks
|
|
General disorders
broken tooth
|
7.1%
1/14 • Number of events 1 • 16 weeks
|
0.00%
0/8 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
lesion removed from ear
|
7.1%
1/14 • Number of events 1 • 16 weeks
|
0.00%
0/8 • 16 weeks
|
|
Surgical and medical procedures
inguinal hernia repair
|
7.1%
1/14 • Number of events 1 • 16 weeks
|
0.00%
0/8 • 16 weeks
|
|
General disorders
sinusitis
|
0.00%
0/14 • 16 weeks
|
12.5%
1/8 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
atypical chest pain
|
0.00%
0/14 • 16 weeks
|
12.5%
1/8 • Number of events 1 • 16 weeks
|
|
General disorders
sore throat
|
0.00%
0/14 • 16 weeks
|
12.5%
1/8 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
bursitis
|
0.00%
0/14 • 16 weeks
|
12.5%
1/8 • Number of events 1 • 16 weeks
|
|
Surgical and medical procedures
lipoma removal
|
0.00%
0/14 • 16 weeks
|
0.00%
0/8 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
DJD worse
|
0.00%
0/14 • 16 weeks
|
25.0%
2/8 • Number of events 2 • 16 weeks
|
Additional Information
Arnold E. Postlethwaite,MD Principal Investigator
Memphis VAMC
Phone: 901 448 5774
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place