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ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate

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ClinicalTrials.gov Identifier: NCT02387762
Recruitment Status : Completed
First Posted : March 13, 2015
Results First Posted : March 26, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: acalabrutinib
Drug: Placebo
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ACP-196 + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
Period Title: Overall Study
Started 16 15
Completed 15 15
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title ACP-196 + Methotrexate Placebo + Methotrexate Total
Hide Arm/Group Description Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week Total of all reporting groups
Overall Number of Baseline Participants 16 15 31
Hide Baseline Analysis Population Description
Intent-to-treat population, which included all randomized subjects
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  62.5%
12
  80.0%
22
  71.0%
>=65 years
6
  37.5%
3
  20.0%
9
  29.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 31 participants
61.3  (7.21) 56.8  (7.92) 59.1  (7.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Female
14
  87.5%
13
  86.7%
27
  87.1%
Male
2
  12.5%
2
  13.3%
4
  12.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   6.7%
1
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   6.7%
1
   3.2%
Black or African American
2
  12.5%
3
  20.0%
5
  16.1%
White
14
  87.5%
10
  66.7%
24
  77.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 15 participants 31 participants
16 15 31
DAS28-CRP at baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on Scale
Number Analyzed 16 participants 15 participants 31 participants
6.29  (1.242) 6.29  (1.220) 6.29  (1.211)
[1]
Measure Description: Using the scores on the scale, measure disease activity score from the DAS28 scale and results from the C-reactive protein at baseline.
Duration of rheumatoid arthritis since initial diagnosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 31 participants
10.3  (7.52) 7.8  (8.12) 9.1  (7.78)
[1]
Measure Description: To measure duration of rheumatoid arthritis since initial diagnosis at baseline
Methotrexate dosing at baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg/week
Number Analyzed 16 participants 15 participants 31 participants
16.9  (6.49) 17.7  (5.22) 17.3  (5.82)
[1]
Measure Description: To measure methotrexate exposure at baseline
1.Primary Outcome
Title Disease Activity Score 28-CRP (DAS28-CRP) at Week 4
Hide Description Disease activity score 28 - C-reactive protein (DAS28-CRP) is a score to measure disease activity in patients with rheumatoid arthritis by aggregating data of 28 joints, and is calculated by the scores on scale using the following variables: The number of swollen and tender joints, CRP level, and patient's global assessment of disease activity. The total score of the DAS28 values may range from 2.0 to 10.0 while higher values mean a higher disease activity.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population, which included all randomized subjects
Arm/Group Title ACP 196 + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description:
Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week
Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Scores on scale
5.40  (1.563) 5.05  (1.639)
Time Frame From the date of the first dose of study drug up to 30 days after the date of the last dose of study drug, up to 6 months.
Adverse Event Reporting Description Subjects with multiple events for a given system organ class (SOC) and preferred term (PT) were counted only once for each SOC and PT. If the same event term was reported more than once for a subject, only the event with the highest grade was included.
 
Arm/Group Title ACP-196 + Methotrexate Placebo + Methotrexate
Hide Arm/Group Description Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
All-Cause Mortality
ACP-196 + Methotrexate Placebo + Methotrexate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
ACP-196 + Methotrexate Placebo + Methotrexate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ACP-196 + Methotrexate Placebo + Methotrexate
Affected / at Risk (%) Affected / at Risk (%)
Total   10/16 (62.50%)   6/15 (40.00%) 
Blood and lymphatic system disorders     
Anaemia  1  2/16 (12.50%)  0/15 (0.00%) 
Leukopenia  1  1/16 (6.25%)  0/15 (0.00%) 
Thrombocytosis  1  1/16 (6.25%)  0/15 (0.00%) 
Leukocytosis  1  0/16 (0.00%)  0/15 (0.00%) 
Gastrointestinal disorders     
Diarrhea  1  1/16 (6.25%)  1/15 (6.67%) 
Nausea  1  1/16 (6.25%)  1/15 (6.67%) 
Vomiting  1  1/16 (6.25%)  0/15 (0.00%) 
General disorders     
Oedema peripheral  1  1/16 (6.25%)  1/15 (6.67%) 
Injury, poisoning and procedural complications     
Contusion  1  1/16 (6.25%)  0/15 (0.00%) 
Clavicle fracture  1  0/16 (0.00%)  1/15 (6.67%) 
Fall  1  0/16 (0.00%)  1/15 (6.67%) 
Hip Fracture  1  0/16 (0.00%)  1/15 (6.67%) 
Investigations     
Full Blood Count decreased  1  1/16 (6.25%)  0/15 (0.00%) 
Blood uric acid increased  1  0/16 (0.00%)  1/15 (6.67%) 
Metabolism and nutrition disorders     
Hypochloraemia  1  1/16 (6.25%)  0/15 (0.00%) 
Hyponatraemia  1  1/16 (6.25%)  0/15 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc degeneration  1  1/16 (6.25%)  0/15 (0.00%) 
Musculoskeletal chest pain  1  1/16 (6.25%)  0/15 (0.00%) 
Rheumatoid arthritis  1  0/16 (0.00%)  1/15 (6.67%) 
Nervous system disorders     
Dizziness  1  1/16 (6.25%)  0/15 (0.00%) 
Lethargy  1  0/16 (0.00%)  1/15 (6.67%) 
Somnolence  1  0/16 (0.00%)  1/15 (6.67%) 
Renal and urinary disorders     
Haematuria  1  1/16 (6.25%)  0/15 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pharyngeal erythema  1  0/16 (0.00%)  1/15 (6.67%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Site and PI can publish/publicly present the results of the study only with prior written consent of Sponsor or otherwise after expiry of 12 months following completion of the study. Site and PI agree to provide 45 days written notice to Sponsor prior to submission for publication or presentation.
Results Point of Contact
Name/Title: Ahmed Hamdy, MD, VP of Early Development
Organization: Acerta Pharma
Phone: 650-591-2800 ext 145
Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02387762     History of Changes
Other Study ID Numbers: ACE-RA-001
First Submitted: March 1, 2015
First Posted: March 13, 2015
Results First Submitted: January 28, 2019
Results First Posted: March 26, 2019
Last Update Posted: April 2, 2019