Psoriatic ArthritisPhase 2NCT00534313
Safety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis
A Phase 2 study testing Abatacept in people with Psoriatic Arthritis, run by Bristol-Myers Squibb at 44 sites in 12 countries.
Trial summary
The purpose of this study is to determine an optimal abatacept dosing regimen for the treatment of active arthritis due to psoriatic arthritis in patients who have had a prior inadequate response to disease-modifying antirheumatic drugs, including methotrexate and tumor necrosis factor alpha-blockade compounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 191 participants
- Where
- 44 sitesin 12 countries
- Study dates
- Nov 2007to May 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting classification criteria for psoriatic arthritis for a duration of disease of at least 3 months
- Prior failure (inefficacy or intolerance) of therapy with disease-modifying antirheumatic drugs; if patient had prior failure of methotrexate, he or she must have been taking at least 15 mg per week for at least 2 months
- If recent failure(inefficacy or intolerance) of a tumor necrosis factor α-blockade compound, participant must be washed out prior to first dose: 56 days for infliximab and 28 days for etanercept and adalimumab
- Disease activity as defined by a tender joint count of ≥3, swollen joint count of ≥3, and clinically detectable synovitis at screening and Day 01 (prior to infusion)
- Active psoriasis with a qualifying target lesion ≥2 cm in diameter
- Able to undergo magnetic resonance imaging
- Use of appropriate birth control by women of child bearing potential (WOCBP)
Who cannot join
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of investigational product
- Women who are pregnant or breastfeeding or who plan to become pregnant or to start breastfeeding during the duration of the study
- Women with a positive pregnancy test on enrollment or prior to investigational product administration.
- Participants scheduled for or anticipating joint replacement surgery.
- Those with a recent history of clinically significant drug or alcohol abuse
- Concomitant illness that in the investigator's opinion is likely to require systemic glucocorticosteroid therapy during the study (for example: moderate to severe asthma)
Show all 16Show fewer
- Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, pulmonary, cardiac, neurologic, ophthalmologic, or cerebral disease.
- Unwillingness or inability to undergo screening based on current local or country guidelines/standards to evaluate the presence of cancer
- Cancer within the last 5 years
- Current malignancy or signs of possible malignancy detected by screening procedures for which the workup to exclude malignancy has not been completed or malignancy cannot be excluded
- At risk for or history (within 3 years) of tuberculosis
- Any serious bacterial infection within the last 3 months, not treated and resolved with antibiotics, or any chronic bacterial infection (such as, but not limited to, chronic pyelonephritis, osteomyelitis, and bronchiectasis)
- Evidence of active or latent bacterial or viral infection infections at the time of potential enrollment
- Herpes zoster or cytomegalovirus resolving less than 2 months prior to signing informed consent
- Receipt of any live vaccines within 3 months of the anticipated first dose of study medication or anticipation of the need for a live vaccine at any time during and for 3 months after the duration of the study
- Long-term period participants: Must have met eligibility criteria for short-term period and completed short-term (24-week) period of the study
Trial locations and contacts
44 sites in 12 countries.
44 sites in 12 countries
United States19 sites
Chase, Walter F.
Austin, Texas, 78705
Joao Nascimento
Bridgeport, Connecticut, 06606
Arthritis Clinic & Carolina Bone & Joint, Pa
Charlotte, North Carolina, 28210
Deaconess Hospital
Cincinnati, Ohio, 45219
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
St. Paul Rheumatology P.A.
Eagan, Minnesota, 55121
Rheumatology Associates Of North Alabama
Huntsville, Alabama, 35801
Midwest Arthritis Center
Kalamazoo, Minnesota, 49048
Justus Fiechtner, Md, Mph
Lansing, Michigan, 48910
Health Research Of Oklahoma
Oklahoma City, Oklahoma, 73103
Desert Medical Advances
Palm Desert, California, 92260
Stanford University School Of Medicine
Palo Alto, California, 94304
Sarasota Arthritis Research Center
Sarasota, Florida, 34239
Seattle Rheumatology Associates
Seattle, Washington, 98104
Arthritis Northwest
Spokane, Washington, 99204
New England Research Associates, Llc
Trumbull, Connecticut, 06611
Boling Clinical Trials
Upland, California, 91786
Rheumatic Disease Associates, Ltd.
Willow Grove, Pennsylvania, 19090
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610
Canada4 sites
Local Institution
Montreal, Quebec, H2L 1S6
Local Institution
Québec, Quebec, G1W 4R4
Local Institution
St. John's, Newfoundland and Labrador, A1B 3E1
Local Institution
Trois-Rivières, Quebec, G8Z 1Y2
Argentina3 sites
Local Institution
Capital Federal, Buenos Aires, 1015
Local Institution
Rosario, Santa Fe Province, 2000
Local Institution
Santa Fe, Santa Fe Province, 3000
Australia3 sites
Local Institution
Cairns, Queensland, 4872
Local Institution
Fitzroy, Melbourne, Victoria, 3065
Local Institution
Maroochydore, Queensland, 4558
France3 sites
Local Institution
Chambray-lès-Tours, 37170
Local Institution
Lille, 59037
Local Institution
Montpellier, 34295
Germany3 sites
Local Institution
Frankfurt am Main, 60590
Local Institution
Hamburg, 22081
Local Institution
Hildesheim, 31134
Italy3 sites
Local Institution
Naples, 80131
Local Institution
Potenza, 85100
Local Institution
Reggio Emilia, 42100
About this study
Official title: A Phase IIB, Multi-Dose, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis
The purpose of this study is to determine an optimal abatacept dosing regimen for the treatment of active arthritis due to psoriatic arthritis in patients who have had a prior inadequate response to disease-modifying antirheumatic drugs, including methotrexate and tumor necrosis factor alpha-blockade compounds.
- Conditions
- Psoriatic Arthritis
- Being tested
- Abatacept, Placebo
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
Also called Orencia, BMS-188667
Solution, intravenous, monthly, short-term = 24 weeks (6 months)
PlaceboDrug
Solution, intravenous, placebo (double dummy), monthly, short-term = 24 weeks (6 months)
| Study group | Role | What they receive |
|---|---|---|
| Abatacept (30/10) | Active comparator | Abatacept (30 mg/kg) was administered as intravenous (iv) infusion over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. The dose was calculated based on screening visit weight of participants for dosing on Days 1 and 15 followed by fixed dosing as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg) thereafter. Receives: Drug: Abatacept |
| Abatacept (10/10) | Active comparator | Abatacept (10 mg/kg) was administered as iv infusion over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 in the double-blind period and continued for next 18 months in the open-label period till Day 729. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg). Receives: Drug: Abatacept |
| Abatacept (3/3) | Active comparator | Abatacept (3 mg/kg) was administered as iv infusion over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. The dose was calculated based on screening visit weight of participants. Receives: Drug: Abatacept |
| Placebo | Placebo comparator | Placebo solution (5% dextrose in water for injection, 0.9% sodium chloride injection) by iv infusion was administered on Days 1, 15, and 29 and every 28 days thereafter till Day 141. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest
Presp=prespecified; acute= ≤1 hour after start of infusion; periinfusional= ≤24 hours after start of infusion. AE=any new unfavorable symptom or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=an unfavorable medical event that at any dose results in death, significant disability, drug dependency/abuse, hospitalization or prolonged hospitalization; is life-threatening, an important medical event, or a congenital anomaly/birth defect. Drug-related=possibly, probably, or certainly related and of unknown relationship to study drug.
Measured: From Day 169 to Day 729
Short-term Period: Number of Participants With ACR 20 Response at Day 169
An ACR 20 responder was a participant who had a reduction of 20% or more from baseline in scores for both tender and swollen joints and had a reduction from baseline of 20% or more in 3 out of the following 5 assessments: participant's assessment of disease activity, participant's global assessment of disease activity, investigator's global assessment of disease activity, participant's assessment of physical function by HAQ-DI, and Disease Activity Score 28-C reactive protein.
Measured: At Day 169 from Baseline
Secondary outcomes (21)
Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729
An ACR 20 (50, 70, 90) responder was a participant whose counts for both tender and swollen joints was reduced by 20% (50%, 70%, 90%, respectively) or more from baseline and who had a reduction of 20% (50%, 70%, 90%, respectively) or more from baseline in 3 of the following assessments: participant's assessment of disease activity, participant's global assessment of disease activity, Investigators Global Response, participant's assessment of physical function by Health Assessment Questionnaire Disability Index, and Disease Activity Score 28 based on C-reactive protein.
Measured: At Days 365 and 729 from Baseline
Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729
IGA score indicates lesion induration, scaling, and erythema: 0=clear (no signs of plaque psoriasis except for residual discoloration); 1=almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2=mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3=moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).
Measured: From Day 169 to Days 365 and 729
Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729
Target lesion score is a measurement of the degree of erythema, induration, and scale of a psoriatic lesion, at least 2 cm in diameter, selected as a target for response throughout the study period. The scores assigned were 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.
Measured: From Baseline to Days 365 and 729
Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729
PCS=physical component score; MCS=mental component score. The SF-36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
Measured: At Days 365 and 729 from baseline
Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729
Per the HAQ-DI, participants assessed their own ability to perform the following tasks: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity over a period by marking their responses on a questionnaire. Scoring of the HAQ-DI: 0=without any difficulty; 1=with some difficulty; 2=with much difficulty); and 3=unable to do. Greater score=greater disability. Responders with a >= 0.3 unit decrease in index scores from baseline to days 365 and 729 were considered to be improved.
Measured: Days 365 and 729 from baseline
Short-term Period: Number of Participants With Marked Abnormalities in Hematology
LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormalities are laboratory measurements marked as abnormal, per predefined study criteria, at any study time point. Criteria: Hemoglobin >3 g/dL decrease from pre-Rx value; hematocrit <0.75*pre-Rx value; erythrocytes <0.75*pre-Rx value; platelets <0.67*LLN (or, if pre-Rx value <LLN, <0.5*pre-Rx value and <100000/mm^3) or >1.5*ULN.
Measured: From Baseline to Day 169
Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued)
LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Laboratory measurements are marked as abnormal per predefined study criteria, at any study time point. Criteria for the data presented. Leukocytes <0.75*LLN or >1.25*ULN (or, if pre-Rx value <LLN, <0.8*pre-Rx or >ULN. If pre-Rx value >ULN, >1.2*pre-Rx or <LLN); neutrophils+bands (absolute) <1.00*10^3 c/uL; lymphocytes (absolute) <0.75*10^3 c/uL or >7.50*10^3 c/uL; monocytes (absolute) >2000/mm^3; basophils (absolute) >0.40*10^3 c/uL; eosinophils (absolute) >0.75*10^3 c/uL.
Measured: From Baseline to Day 169
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry
ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT) >2*ULN (if pre-Rx >ULN, >3*pre-Rx); aspartate aminotransferase (AST), alanine transaminase (ALT) >3*ULN (if pre-Rx >ULN, >4*pre-Rx); bilirubin (total) >2*ULN (if pre-Rx >ULN, >4*pre-Rx); blood urea nitrogen (BUN) >2*pre-Rx; creatinine >1.5*pre-Rx.
Measured: Baseline to Day 169
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)
LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Sodium <0.95*LLN or >1.05*ULN (if pre-Rx<LLN, <0.95*pre-Rx or >ULN. If pre-Rx >ULN,>1.05* pre-Rx or <LLN); potassium, chloride <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN); calcium <0.8*LLN or >1.2*ULN (if pre-Rx <LLN,<0.75* pre-Rx or >ULN. If pre-Rx >ULN, >1.25* pre-Rx or <LLN); phosphorous <0.75*LLN or >1.25*ULN (if pre-Rx <LLN, <0.67*pre-Rx or >ULN. If pre-Rx >ULN, >1.33*pre-Rx or <LLN.
Measured: Baseline to Day 169
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)
LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Glucose <65 or >220 mg/dL; glucose (fasting)<0.8*LLN or >1.5*ULN (if pre-Rx <LLN, <0.8*pre-Rx or >ULN. If pre-Rx >ULN, t>2.0*pre-Rx or <LLN). Protein (total) <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN). Albumin <0.9*LLN (if pre-Rx <LLN, <0.75* pre-Rx). Uric acid >1.5*ULN; if pre-Rx >ULN or >2*pre-Rx value.
Measured: From Baseline to Day 169
Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis
Pre-Rx=pretreatment. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase, red blood cells (RBC), white blood cells (WBC) >=2+ (or, if value >=4, or if pre-Rx value=0 or 0.5, >= 2* or if pre-RX value =1, >=3, or if pre-Rx =2 or 3, >=4).
Measured: From Baseline to Day 169
Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
Measured: From Baseline to Day 169
Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169
Score indicates lesion induration, scaling, and erythema: 0 = clear (no signs of plaque psoriasis except for residual discoloration); 1 = almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2 = mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3 = moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).
Measured: At Day 169 from Baseline
Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169
Target lesion score measures the degree of erythema, induration, and scale of a psoriatic lesion with a diameter of at least 2 cm, selected as a target for response throughout the study period. Scores: 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.
Measured: At Day 169 from Baseline
Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C)
Meso Scale Discovery electrochemiluminescence, a validated, sensitive immunoassay technique (anti-abatacept assay C) was used to measure serum levels of abatacept-specific antibodies against the whole molecule (both the CTLA4 and possibly immunoglobulin G portion [anti-abatacept antibody].
Measured: From Baseline to Day 169
Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169
PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
Measured: At Day 169 from Baseline
Short-term Period: Mean Serum Concentrations of Abatacept
Abatacept was assayed using a validated enzyme linked immunosorbent assay method (ELISA). Serum concentration versus time data was analyzed in the descriptive pharmacokinetic (PK) analysis.
Measured: Days 1, 15, 29, 57, 85, 113, 141, and 169
Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept
Abatacept was assayed using a validated ELISA method. Cmin of abatacept was obtained from concentration versus time data.
Measured: Days 1, 15, 29, 57, 85, 113, 141, and 169
Short-term Period: Population Pharmacokinetic (POPPK) Analysis of the Pharmacokinetic (PK) Parameters
PK data: summaries of concentrations and concentration versus time plots were obtained. These data were to be used to develop a POPPK model using a nonlinear mixed-effects model. Prediction of PK data for each of the 3 abatacept treatment groups using POPPK methodology was not performed, because it would not provide any relevant information over the observed PK data.
Measured: Days 1, 15, 29, 57, 85, 113, 141, and 169
Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169
PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
Measured: At Day 169 from Baseline
Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169
The HAQ-DI assesses a participant's ability to perform the following tasks: dress/groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity over a period by marking their response on a questionnaire. Responses/scores range from: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=to unable to do. Higher total score=greater disability.
Measured: At Day 169 from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2008
- Study completionMay 2011
Why it stopped: Lack of efficacy with respect to skin-related lesions in the short-term phase
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534313
- Sponsor's protocol ID
- IM101-158
- Other IDs
- EUDRACT 2007-004241-15
- Status last verified
- Jul 2012
- First submitted
- 20 Sep 2007
- Last updated
- 1 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ostergaard M, Bird P, Pachai C, Du S, Wu C, Landis J, Fuerst T, Ahmad HA, Connolly SE, Conaghan PG. Implementation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Scoring System in a randomized phase IIb study of abatacept in psoriatic arthritis. Rheumatology (Oxford). 2022 Nov 2;61(11):4305-4313. doi: 10.1093/rheumatology/keac073.
PubMed 35137002Mease P, Genovese MC, Gladstein G, Kivitz AJ, Ritchlin C, Tak PP, Wollenhaupt J, Bahary O, Becker JC, Kelly S, Sigal L, Teng J, Gladman D. Abatacept in the treatment of patients with psoriatic arthritis: results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial. Arthritis Rheum. 2011 Apr;63(4):939-48. doi: 10.1002/art.30176.
PubMed 21128258
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIB, Multi-Dose, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT00534313
- Acronym / sponsor ID
- IM101-158
- Conditions
- Psoriatic Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy with respect to skin-related lesions in the short-term phase
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 24 Sep 2007 (estimated)
- Results
- Posted 22 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine an optimal abatacept dosing regimen for the treatment of active arthritis due to psoriatic arthritis in patients who have had a prior inadequate response to disease-modifying antirheumatic drugs, including methotrexate and tumor necrosis factor alpha-blockade compounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Abatacept (30/10) | Active comparator | Drug: AbataceptAbatacept (30 mg/kg) was administered as intravenous (iv) infusion over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. The dose was calculated based on screening visit weight of participants for dosing on Days 1 and 15 followed by fixed dosing as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg) thereafter. |
| Abatacept (10/10) | Active comparator | Drug: AbataceptAbatacept (10 mg/kg) was administered as iv infusion over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 in the double-blind period and continued for next 18 months in the open-label period till Day 729. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg). |
| Abatacept (3/3) | Active comparator | Drug: AbataceptAbatacept (3 mg/kg) was administered as iv infusion over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. The dose was calculated based on screening visit weight of participants. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo solution (5% dextrose in water for injection, 0.9% sodium chloride injection) by iv infusion was administered on Days 1, 15, and 29 and every 28 days thereafter till Day 141. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Meeting classification criteria for psoriatic arthritis for a duration of disease of at least 3 months
- Prior failure (inefficacy or intolerance) of therapy with disease-modifying antirheumatic drugs; if patient had prior failure of methotrexate, he or she must have been taking at least 15 mg per week for at least 2 months
- If recent failure(inefficacy or intolerance) of a tumor necrosis factor α-blockade compound, participant must be washed out prior to first dose: 56 days for infliximab and 28 days for etanercept and adalimumab
- Disease activity as defined by a tender joint count of ≥3, swollen joint count of ≥3, and clinically detectable synovitis at screening and Day 01 (prior to infusion)
- Active psoriasis with a qualifying target lesion ≥2 cm in diameter
Key exclusion criteria (16 listed)
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of investigational product
- Women who are pregnant or breastfeeding or who plan to become pregnant or to start breastfeeding during the duration of the study
- Women with a positive pregnancy test on enrollment or prior to investigational product administration.
- Participants scheduled for or anticipating joint replacement surgery.
- Those with a recent history of clinically significant drug or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbataceptAlso: Orencia, BMS-188667Solution, intravenous, monthly, short-term = 24 weeks (6 months) | Drug | Abatacept (10/10), Abatacept (3/3), Abatacept (30/10) |
| PlaceboSolution, intravenous, placebo (double dummy), monthly, short-term = 24 weeks (6 months) | Drug | Placebo |
Primary outcome
Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest
Time frame: From Day 169 to Day 729
Presp=prespecified; acute= ≤1 hour after start of infusion; periinfusional= ≤24 hours after start of infusion. AE=any new unfavorable symptom or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=an unfavorable medical event that at any dose results in death, significant disability, drug dependency/abuse, hospitalization or prolonged hospitalization; is life-threatening, an important medical event, or a congenital anomaly/birth defect. Drug-related=possibly, probably, or certainly related and of unknown relationship to study drug.
Short-term Period: Number of Participants With ACR 20 Response at Day 169
Time frame: At Day 169 from Baseline
An ACR 20 responder was a participant who had a reduction of 20% or more from baseline in scores for both tender and swollen joints and had a reduction from baseline of 20% or more in 3 out of the following 5 assessments: participant's assessment of disease activity, participant's global assessment of disease activity, investigator's global assessment of disease activity, participant's assessment of physical function by HAQ-DI, and Disease Activity Score 28-C reactive protein.
21 secondary outcomes
Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729
Time frame: At Days 365 and 729 from Baseline
Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729
Time frame: From Day 169 to Days 365 and 729
Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729
Time frame: From Baseline to Days 365 and 729
Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729
Time frame: At Days 365 and 729 from baseline
Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729
Time frame: Days 365 and 729 from baseline
Short-term Period: Number of Participants With Marked Abnormalities in Hematology
Time frame: From Baseline to Day 169
Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued)
Time frame: From Baseline to Day 169
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry
Time frame: Baseline to Day 169
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)
Time frame: Baseline to Day 169
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)
Time frame: From Baseline to Day 169
Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis
Time frame: From Baseline to Day 169
Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs
Time frame: From Baseline to Day 169
Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169
Time frame: At Day 169 from Baseline
Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169
Time frame: At Day 169 from Baseline
Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C)
Time frame: From Baseline to Day 169
Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169
Time frame: At Day 169 from Baseline
Short-term Period: Mean Serum Concentrations of Abatacept
Time frame: Days 1, 15, 29, 57, 85, 113, 141, and 169
Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept
Time frame: Days 1, 15, 29, 57, 85, 113, 141, and 169
Short-term Period: Population Pharmacokinetic (POPPK) Analysis of the Pharmacokinetic (PK) Parameters
Time frame: Days 1, 15, 29, 57, 85, 113, 141, and 169
Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169
Time frame: At Day 169 from Baseline
Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169
Time frame: At Day 169 from Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35137002Ostergaard M, Bird P, Pachai C, Du S, Wu C, Landis J, Fuerst T, Ahmad HA, Connolly SE, Conaghan PG. Implementation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Scoring System in a randomized phase IIb study of abatacept in psoriatic arthritis. Rheumatology (Oxford). 2022 Nov 2;61(11):4305-4313. doi: 10.1093/rheumatology/keac073.
- Derived from this study: PubMed 21128258Mease P, Genovese MC, Gladstein G, Kivitz AJ, Ritchlin C, Tak PP, Wollenhaupt J, Bahary O, Becker JC, Kelly S, Sigal L, Teng J, Gladman D. Abatacept in the treatment of patients with psoriatic arthritis: results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial. Arthritis Rheum. 2011 Apr;63(4):939-48. doi: 10.1002/art.30176.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
44 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abatacept in people with Psoriatic Arthritis, run by Bristol-Myers Squibb at 44 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Canada, Argentina, Australia, France and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest (time frame: From Day 169 to Day 729). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00534313, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2012.