CompletedNCT02387762Updated Apr 2, 2019Results posted

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

A Phase 2 interventional study of acalabrutinib and Placebo in Rheumatoid Arthritis, sponsored by Acerta Pharma BV. Completed at 17 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-04-02.

Sponsored by Acerta Pharma BV · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 31
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.

Read the detailed description

A multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The on-treatment period is 4 weeks with weekly visits to the clinic, followed by a 4-week safety follow-up period after the last dose of ACP-196/placebo. The study was to evaluate the safety, PK, PD, and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate

Conditions studied

Rheumatoid Arthritis

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Keywords

Acalabrutinib

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 31 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Acerta Pharma BV is the lead sponsor of 40 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 3 (25%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Main Inclusion Criteria:

Diagnosis of RA according to the 2010 ACR/EULAR Classification Criteria .
Must be on a stable MTX dose (7.5 to 25 mg/week)
Subjects must be able to read and understand the consent form, complete the study-related procedures, and communicate with the study staff.
Are willing and able to adhere to the study visit schedule, and understand and comply with other protocol requirements.

Main Exclusion Criteria:

Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 5 years.
A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196, or put the study outcomes at undue risk.
Subjects who have taken any investigational drug within the previous 30 days before randomization.
Use of all other synthetic disease-modifying antirheumatic drugs (DMARDS) such as but not limited to leflunomide, azathioprine, cyclosporine, penicillamine or gold salts within 8 weeks of randomization.
Use of etanercept, anakinra, tofacitinib within 4 weeks of randomization.
Use of abatacept, humira, infliximab, or tocilizumab within 8 weeks of randomization.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 31 participants (actual)

Study arms

Experimental
ACP-196 + Methotrexate
Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week
Drug: acalabrutinib
Placebo comparator
Placebo + Methotrexate
Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
Drug: Placebo

Interventions

Drugacalabrutinib
Also known as: methotrexate
DrugPlacebo
Also known as: methotrexate

What researchers measure

Primary outcomes

Disease Activity Score 28-CRP (DAS28-CRP) at Week 4
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

Results

Posted Mar 26, 2019

Participant flow

Participant flow — Overall Study
Milestone	ACP-196 + Methotrexate	Placebo + Methotrexate
Started	16	15
Completed	15	15
Not completed	1	0
Withdrew: Withdrawal by subject	1	0

Outcome measures

PrimaryDisease Activity Score 28-CRP (DAS28-CRP) at Week 4

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
Reported as:: Mean · Scores on scale

Disease Activity Score 28-CRP (DAS28-CRP) at Week 4
Scores on scale	ACP 196 + Methotrexate	Placebo + Methotrexate
Disease Activity Score 28-CRP (DAS28-CRP) at Week 4	5.40 ± 1.563	5.05 ± 1.639

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
ACP-196 + Methotrexate	0/16 (0%)	0/16 (0%)	10/16 (62.5%)
Placebo + Methotrexate	0/15 (0%)	0/15 (0%)	6/15 (40%)

Most frequent other events

Showing 10 of 24

Most frequent other events
Event	ACP-196 + Methotrexate	Placebo + Methotrexate
AnaemiaBlood and lymphatic system disorders	2/16	0/15
DiarrheaGastrointestinal disorders	1/16	1/15
NauseaGastrointestinal disorders	1/16	1/15
Oedema peripheralGeneral disorders	1/16	1/15
Clavicle fractureInjury, poisoning and procedural complications	0/16	1/15
FallInjury, poisoning and procedural complications	0/16	1/15
Hip FractureInjury, poisoning and procedural complications	0/16	1/15
Blood uric acid increasedInvestigations	0/16	1/15
Rheumatoid arthritisMusculoskeletal and connective tissue disorders	0/16	1/15
LethargyNervous system disorders	0/16	1/15

Baseline characteristics

Intent-to-treat population, which included all randomized subjects

Age, Categorical
Age, Categorical(Participants)	ACP-196 + Methotrexate	Placebo + Methotrexate	Total
<=18 years	0	0	0
Between 18 and 65 years	10	12	22
>=65 years	6	3	9

Age, Continuous
Age, Continuous(years)	ACP-196 + Methotrexate	Placebo + Methotrexate	Total
Mean	61.3 ± 7.21	56.8 ± 7.92	59.1 ± 7.78

Sex: Female, Male
Sex: Female, Male(Participants)	ACP-196 + Methotrexate	Placebo + Methotrexate	Total
Female	14	13	27
Male	2	2	4

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	ACP-196 + Methotrexate	Placebo + Methotrexate	Total
American Indian or Alaska Native	0	0	0
Asian	0	1	1
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	2	3	5
White	14	10	24
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	ACP-196 + Methotrexate	Placebo + Methotrexate	Total
United States	16	15	31

DAS28-CRP at baseline
DAS28-CRP at baseline(Scores on Scale)	ACP-196 + Methotrexate	Placebo + Methotrexate	Total
Mean	6.29 ± 1.242	6.29 ± 1.220	6.29 ± 1.211

Duration of rheumatoid arthritis since initial diagnosis
Duration of rheumatoid arthritis since initial diagnosis(years)	ACP-196 + Methotrexate	Placebo + Methotrexate	Total
Mean	10.3 ± 7.52	7.8 ± 8.12	9.1 ± 7.78

Methotrexate dosing at baseline
Methotrexate dosing at baseline(mg/week)	ACP-196 + Methotrexate	Placebo + Methotrexate	Total
Mean	16.9 ± 6.49	17.7 ± 5.22	17.3 ± 5.82

Study locations

17 sites

Pinnacle Research Group
Anniston, Alabama 36207, United States
Achieve Clinical Research
Birmingham, Alabama 35216, United States
Advanced Arthritis Care and Research
Scottsdale, Arizona 85258, United States
TriWest Research Associates, LLC
El Cajon, California 92020, United States
Neuropsychiatric Research Center of Orange County
Orange, California 92868, United States
Pacific Arthritis Center Medical Group
Santa Monica, California 93454, United States
Inland Rheumatology and Osteoporosis Medical Group, Inc
Upland, California 91786, United States
San Marcus Research Clinic, Inc.
Hialeah, Florida 33015, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida 34652, United States
Suncoast Clinical Research
New Port Richey, Florida 34652, United States
The Arthritis Center
Palm Harbor, Florida 34684-3176, United States
Office of George Timothy Kelly, MD
Las Vegas, Nevada 89128, United States
PMG Research of Salisbury
Salisbury, North Carolina 28144, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma 73103-2433, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania 16635, United States
Ramesh C. Gupta, MD
Memphis, Tennessee 38119, United States
Clear Lake Regional Medical Center
Webster, Texas 77598, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02387762
Lead sponsor: Acerta Pharma BV
Responsible party: Sponsor
First posted: Mar 13, 2015
Start date: Apr 2015
Primary completion: May 2016
Completion: Jun 2016
Results posted: Mar 26, 2019
Last update: Apr 2, 2019

Study contacts

Acerta Clinical Trials

study director · Acerta Pharma, LLC

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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