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The Effect of Corticotrophin (ACTH) in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients

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ClinicalTrials.gov Identifier: NCT01948388
Recruitment Status : Completed
First Posted : September 23, 2013
Results First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Gaylis, Norman B., M.D.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Drug: corticotrophin 80 units
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description Ten (10) Patients were treated with 80 U of ACTH once weekly and MTX 12.5-25 mg/week for a period of 6 months. Eight (8) Patients completed the 6 month trial in this group Ten (10) patients were treated with 80 U of ACTH twice a week and MTX 12.5-25 mg/week for a 6 month period. Nine (9) patients completed the trial in this group over the 6 month period.
Period Title: Overall Study
Started 10 10
Completed 8 9
Not Completed 2 1
Arm/Group Title Corticotrophin 80 Units Corticotrophin 80 Units Twice a Week Total
Hide Arm/Group Description

Ten (10) patients will receive 80 units of corticotrophin Subcutaneous (SC) weekly

corticotrophin 80 units: Comparison of different dosages of the drug. Ten patients will receive 80 units of corticotrophin weekly. Ten patients will receive 80 units bi-weekly of corticotrophin

Ten (10) patients will receive 80 units of corticotrophin Subcutaneous (SC) twice a week

corticotrophin 80 units: Comparison of different dosages of the drug. Ten patients will receive 80 units of corticotrophin weekly. Ten patients will receive 80 units bi-weekly of corticotrophin

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  70.0%
7
  70.0%
14
  70.0%
>=65 years
3
  30.0%
3
  30.0%
6
  30.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
60
(49 to 77)
57
(36 to 78)
59
(36 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
9
  90.0%
10
 100.0%
19
  95.0%
Male
1
  10.0%
0
   0.0%
1
   5.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Hide Description To evaluate the effect of the use of 2 doses of corticotrophin (ACTH) as a treatment in patients with early onset rheumatoid arthritis as an alternative to conventional steroid therapy by evaluating the change from baseline in the clinical findings as measured by Clinical Disease Activity Index (CDAI) scores. The CDAI is calculated at the specified time points using the formula: CDAI = SJC(28) + TJC(28) + PGA + EGA SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees) Interpretation: A lower CDAI score from Baseline would mean improvement in disease activity and an increase in CDAI score from Baseline would mean an increase in disease activity or a worsening in disease activity. Scores: 0.0-2.8 = Range for Remission; 2.9-10.0 = Range for Low disease activity; 10.1-22.0 Range for Moderate disease activity; 22.1-76 Range for High disease activity.Total range is from 0-100, with the high scores representing high disease activity.
Time Frame Baseline, Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of Patients who complete 6 months of treatment in both groups doses weekly Group 1, and dosed twice a week Group 2
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Ten (10) Patients were treated with 80 U of ACTH once weekly and MTX 12.5-25 mg/week for a period of 6 months. Eight (8) Patients completed the 6 month trial in this group
Ten (10) patients were treated with 80 U of ACTH twice a week and MTX 12.5-25 mg/week for a 6 month period. Nine (9) patients completed the trial in this group over the 6 month period.
Overall Number of Participants Analyzed 9 8
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline remission
0
   0.0%
0
   0.0%
low disease activity
0
   0.0%
0
   0.0%
moderate disease activity
0
   0.0%
0
   0.0%
high disease activity
9
 100.0%
8
 100.0%
Month 3 remission
3
  33.3%
1
  12.5%
low disease activity
2
  22.2%
4
  50.0%
moderate disease activity
4
  44.4%
2
  25.0%
high disease activity
0
   0.0%
1
  12.5%
Month 6 remission
2
  22.2%
3
  37.5%
low disease activity
4
  44.4%
3
  37.5%
moderate disease activity
2
  22.2%
2
  25.0%
high disease activity
1
  11.1%
0
   0.0%
2.Secondary Outcome
Title Evaluation of MRI Structural Improvements
Hide Description To compare the number of patients who have synovitis, oseitis and erosions at Baseline, Month 3 and Month 6. Normal range for synovitis, osteitis and erosions is zero (0)
Time Frame Baseline, 3 months, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of Patients who complete 6 months of treatment in both groups doses weekly Group 1, and dosed twice a week Group 2
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Patients being weekly dosed with ACTH at 80 units
Patients receiving twice weekly doing of 80 units ACTH
Overall Number of Participants Analyzed 9 8
Measure Type: Number
Unit of Measure: participants
Baseline : synovitis 8 7
Baseline : osteitis 8 4
Baseline : erosions 9 8
Month 3 : synovitis 6 7
Month 3 : osteitis 6 6
Month 3 : erosions 9 8
Month 6 : synovitis 5 7
Month 6 : osteitis 4 4
Month 6 : erosions 7 8
3.Secondary Outcome
Title Number of Participants With Increased or Decreased Erosions of the Hand and Wrist
Hide Description

Comparison of the change in the number of erosions seen in the joints of the hand and wrist as measured by Magnetic Resonance Imaging (MRI) findings.

Regression indicates improvement in the number of erosions seen from Baseline and Progression indicates worsening in the number of erosions seen from Baseline. Normal range is zero (0).

Time Frame Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of Patients with erosions who completed 6 months of treatment in both groups doses weekly Group 1, and dosed twice a week Group 2
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Patients being weekly dosed with ACTH at 80 units
Patients receiving twice weekly doing of 80 units ACTH
Overall Number of Participants Analyzed 9 8
Measure Type: Number
Unit of Measure: participants
Month 3 : Progressed erosions 1 3
Month 3 : Regressed erosions 0 2
Month 6 : Progressed erosions 2 2
Month 6 : Regressed erosions 1 2
4.Secondary Outcome
Title Comparison of Clinical Disease Activity Index (CDAI) Scores to Positive Magnetic Resonance Imaging (MRI) Findings
Hide Description

Comparison of the clinical findings as measured by the Clinical Disease Activity Index (CDAI) versus the structural findings as measured by Magnetic Resonance Imaging (MRI). Improvement is measured as a reduction in CDAI score from Baseline to Month 6 and improvement in MRI is regression of erosions, oseitis and synovitis at month 6. Norman MRI score is zero (0).

CDAI: 0.0-2.8 remission; 2.9-10.0 low disease activity; 10.1-22 moderate disease activity; 22.1-76 high disease activity. A decrease in CDAI score is improvement

Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of Patients who complete 6 months of treatment in both groups doses weekly Group 1, and dosed twice a week Group 2
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Patients being weekly dosed with ACTH at 80 units
Patients receiving twice weekly doing of 80 units ACTH
Overall Number of Participants Analyzed 9 8
Measure Type: Number
Unit of Measure: participants
# of patients whose CDAI score improved 8 8
# of patients whose overall MRI improved 6 5
5.Other Pre-specified Outcome
Title Participants With Increased and Decreased C-Reactive Protein (CRP) Values and Erythrocyte Sedimentation Rates (ESR)
Hide Description comparisons not statistical analysis will be made from Baseline and Month 6 of the C- reactive Protein (CRP) values and Erythrocyte Sedimentation Rate (ESR) to determine the number of patients whose test result improved or worsenedCRP value (normal range <1.0 mg/dl). ESR (normal range 0-28 mm/hr) . If the value is increased, the disease activity worsened. If the value is reduced the disease activity is improved.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of Patients who complete 6 months of treatment in both groups doses weekly Group 1, and dosed twice a week Group 2
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Patients being weekly dosed with ACTH at 80 units
Patients receiving twice weekly doing of 80 units ACTH
Overall Number of Participants Analyzed 9 8
Measure Type: Count of Participants
Unit of Measure: Participants
CRP Values # of patient with Decreased values
8
  88.9%
7
  87.5%
# of patients with Increased values
1
  11.1%
1
  12.5%
ESR Values # of patient with Decreased values
9
 100.0%
8
 100.0%
# of patients with Increased values
0
   0.0%
0
   0.0%
Time Frame all adverse events were collected from the date of signing Informed Consent and Discontinuation or Completion of the trial. There were no adverse events either serious or non-serious to be reported.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description Ten (10) Patients were treated with 80 U of ACTH once weekly and MTX 12.5-25 mg/week for a period of 6 months. Eight (8) Patients completed the 6 month trial in this group Ten (10) patients were treated with 80 U of ACTH twice a week and MTX 12.5-25 mg/week for a 6 month period. Nine (9) patients completed the trial in this group over the 6 month period.
All-Cause Mortality
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Joanne Sagliani
Organization: Arthritis & Rheumatic Disease Specialties
Phone: 3059324162
Responsible Party: Gaylis, Norman B., M.D.
ClinicalTrials.gov Identifier: NCT01948388     History of Changes
Other Study ID Numbers: RA2013-01
First Submitted: September 9, 2013
First Posted: September 23, 2013
Results First Submitted: May 23, 2018
Results First Posted: January 18, 2019
Last Update Posted: January 18, 2019