Sjögren's SyndromePhase 3ASAPIIINCT02067910
Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome
A Phase 3 study testing Abatacept SC in people with Sjögren's Syndrome, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Primary Sjögren's syndrome (pSS) is a common chronic auto-immune disease, characterised by inflammation of the exocrine glands, resulting in progressive dryness of the eyes and the mouth. Furthermore, many patients experience extraglandular symptoms such as restricting fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjögren's Syndrome
- What is being tested?
- Abatacept SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2014to Aug 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Signed written informed consent
- ESSDAI ≥ 5
- Female or male ≥ 18 years
- pSS according to the American European Consensus Group (AECG) classification criteria (6)
- Disease duration ≤ 7 years at the moment of inclusion
- pSS proven by parotid gland biopsy with characteristic features of SS
- Women of child bearing (WOCBP) potential must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 10 weeks after the last dose of study drug in such a manner that the risk of pregnancy is minimized.
- Sexually active fertile men must use effective birth control if their partners are WOCBP
Who cannot join
- Presence of any other connective tissue disease.
- Flow rate of stimulated whole saliva \<0.05 ml/min in patients without extraglandular manifestations.
- Positive pregnancy test or breast-feeding women.
- Women with a child-bearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the entire study period.
- History of alcohol or drug abuse or current alcohol or drug abuse.
- History of any malignancy in the past 5 years, including MALT lymphoma in the last 5 years, or with a current suspicion for cancer, other than non-melanoma skin cell cancers (NMSC), cured by local resection or carcinoma in situ. Existing NMSCs should be removed, the lesion site healed, and residual cancer ruled out before administration of the study drug.
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- Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of human immunodeficiency virus (HIV) detected during screening.
- History of chronic or recurrent serious infections. (e.g. chronic pyelonephritis, osteomyelitis or bronchiectasis).
- Subjects with serious bacterial infections within the last 3 month, unless treated and resolved with antibiotics
- Subjects with herpes zoster or cytomegalovirus that resolved less than 2 months before potential enrollment.
- Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be subjects with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).
- Subjects must not be positive for hepatitis B surface antigen.
- Subjects who are positive for hepatitis C antibody if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay.
- Subjects who have received any live vaccines within 3 months before potential enrollment.
- Underlying cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal, haematological or neurological conditions, chronic or latent infectious diseases or immune deficiency which places the patient at an unacceptable risk for participation in the study.
- Use of prednisone ≤10 mg less than 1 month before inclusion.
- Use of pilocarpine, hydroxychloroquine, methotrexate, cyclophosphamide, cyclosporin, azathioprine, mycophenolate mofetil (MMF) and leflunomide less than 1 month before inclusion.
- Use of biologicals:
- Use of abatacept less than 6 months or rituximab less than 12 months before inclusion
- Previous use of abatacept or rituximab if treatment with abatacept or rituximab was discontinued because of safety reasons or failure of treatment
- Previous use of other biological DMARDS than abatacept or rituximab, either marketed or under investigation
- Lab abnormalities:
- Serum creatine ≥2.8 mg/dl (250 µmol/l)
- ASAT or ALAT outside 1.5 x upper normal range of the laboratory
- Hb ≤ 9 g/dl (5.6 mmol/l) for males and 8.5 g/dl (5.3 mmol/l) for females
- Neutrophil granulocytes less than 0.5 x 109/l
- Platelet count less than 50 x 109/l
- Any other laboratory test results that, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
- Subjects will be asked if they have allergies or adverse drug reactions. The investigator will withdraw subjects at unacceptable risk for participation from the study.
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
- Subjects who are impaired, incapacitated, or incapable of completing study-related assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome (ASAP III Study = Abatacept Sjögren Active Patients Phase III Study)
Primary Sjögren's syndrome (pSS) is a common chronic auto-immune disease, characterised by inflammation of the exocrine glands, resulting in progressive dryness of the eyes and the mouth. Furthermore, many patients experience extraglandular symptoms such as restricting fatigue. Currently, biological agents have been introduced in various systemic autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus. No biological agent has yet been approved for the treatment of pSS. In an open-label study, we have shown that abatacept treatment of pSS patients has promising results (Meiners et al., 2014). Therefore, the aim of this study is to evaluate efficacy and safety of subcutaneous abatacept treatment in pSS in a larger and randomized clinical trial.
Read the detailed description
Background: Primary Sjögren's syndrome (pSS) is a chronic inflammatory and lymphoproliferative disease with autoimmune features. pSS is characterised by a progressive lymphocytic infiltration of the exocrine glands, notably the lacrimal and salivary glands. The main clinical features are a progressive dryness of the eyes, mouth, vagina and skin. Furthermore, various extraglandular manifestations may develop of which restricting fatigue is the most common. Patients may be restricted in their activities and their participation in society, resulting in a reduced health-related quality of life and an impaired socioeconomic status. The latter results in lower employment rates and more disability as compared to the general population. The estimated prevalence of pSS in the general population is between 0.5-2%, which makes pSS, after rheumatoid arthritis (RA), the most common systemic autoimmune disease. Most of the traditional anti-rheumatic drugs used in RA and systemic lupus erythematosus have been tried in pSS with limited results. Currently, biological agents have been introduced in various systemic autoimmune diseases. These biological agents enhance or replace conventional immunosuppressive therapy. In contrast to RA and systemic lupus erythematosus (SLE), no biological agent has yet been approved for the treatment of pSS. Abatacept is a fully human soluble co-stimulation modulator that selectively targets the CD80/CD86:CD28 co-stimulatory signal required for full T-cell activation, and T cell dependent activation of B-cells. We have recently shown in a phase II open label study that Abatacept treatment of pSS patients has promising efficacy results, as reflected by a significant decrease in disease activity indices such as the EULAR Sjögrens Syndrome Disease Activity Index and Patient Reported Index (ESSDAI and ESSPRI) (Meiners et al., 2014). Importantly, we also have shown that Abatacept is safe and side effects are very limited in pSS patients. For these reasons a larger and randomized clinical trial with Abatacept is warranted.
Objective: Primary: to evaluate efficacy of weekly subcutaneous (SC) administration of Abatacept vs placebo on disease activity assessed with ESSDAI at in patients with pSS. Secondary: to assess efficacy of Abatacept on clinical, functional, laboratory, subjective, and histological parameters over 48 weeks in patients with pSS. To evaluate the safety of abatacept, by monitoring serious adverse events (SAE), adverse events (AE) related SAE and AE, treatment discontinuation related to SAE and AE, and lab abnormalities over 48 weeks in patients with pSS. Exploratory: to assess efficacy on laboratory parameters over 48 weeks in patients with pSS.
Study design: The first stage is a 24-week randomized, double-blind, placebo-controlled phase III study to assess the efficacy and safety of Abatacept (weekly SC administration of 125 mg Abatacept or placebo) in patients with pSS. The primary endpoint (ESSDAI) will be evaluated at 24 weeks. The second stage is composed of a 24-week open-label period in which both Abatacept and placebo treated patients will receive Abatacept for 24 weeks. The total study duration will be 48 weeks where after the study will be opened.
Study population: 88 adult pSS patients
Intervention: Weekly subcutaneous administration of 125 mg Abatacept up to 48 weeks.
Main endpoints: The primary endpoint is the difference in ESSDAI score between the Abatacept and the placebo group at 24 weeks. Secondary endpoints are clinical, functional, laboratory, subjective, and histological parameters and the prevalence of adverse events, treatment discontinuation and laboratory abnormalities.
- Conditions
- Sjögren's Syndrome
- Being tested
- Abatacept SC
- Keywords
- Abatacept, Subcutaneous, Sjögren's syndrome, Treatment, Safety, Efficacy
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abatacept SCDrug
Also called Subcutaneous Abatacept, Orencia
Weekly subcutaneous administration of 125 mg Abatacept
| Study group | Role | What they receive |
|---|---|---|
| Abatacept SC | Active comparator | Weekly subcutaneous administration of 125 mg Abatacept during 48 weeks Receives: Drug: Abatacept SC |
| Placebo | Placebo comparator | First phase: Weekly subcutaneous administration of placebo during 24 weeks. Second phase: Weekly subcutaneous administration of 125 mg Abatacept during 24 weeks. Receives: Drug: Abatacept SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
ESSDAI
Measured: 24 weeks
Secondary outcomes (18)
Safety parameters
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) v.14.0.
Measured: Week 4, 8, 12, 24, 28, 32, 36, 48
ESSDAI (at time-points other than 24 weeks)
Measured: Week 0, 4, 8, 12, 28, 32, 36, 48
DAS28(CRP) and DAS28(ESR)
Measured: Week 0, 4, 8, 12, 24, 28, 32, 36, 48
Corticosteroid dose (decrease, stable, increase)
Measured: Week 0, 4, 8, 12, 24, 28, 32, 36, 48
Salivary gland function
Unstimulated and stimulated whole saliva, sialometric and sialochemical analysis of gland-specific saliva
Measured: Week 0, 12, 24, 36 and 48
Tear gland function
Schirmer test, tear-break-up time, ocular staining score, tears collection, determination of auto-antibodies and cytokines, conjunctival impression cytology
Measured: Week 0, 12, 24, 36 and 48
ESSPRI
Measured: 0, 4, 8, 12, 24, 28, 32, 36, and 48.
Patient and Physician Global assessment of disease activity (patGDA, phyGDA)
Measured: 0, 4, 8, 12, 24, 28, 32, 36, and 48
Multidimensional Fatigue Index (MFI)
Measured: week 0, 12, 24, 36, and 48
Health related quality of life (Short Form-36; SF-36)
Measured: week 0, 12, 24, 36, and 48
Patient Acceptable Symptom State (PASS)
Measured: week 0, 12, 24, 36, and 48
Female Sexual Function Index (FSFI)
Measured: week 0, 24 and 48
NRS score vaginal dryness
Measured: Week 0, 24 and 48
Histological change in parotid gland
Follow-up parotid gland biopsy in patients of who a recent (<6 months prior to inclusion) parotid gland biopsy is available.
Measured: Week 24
Laboratory immune markers
Serum levels of ANA and IgM-Rf, Serum levels of anti-SSA, anti-SSB, Immunoglobulins (IgG, IgA, IgM), T and B cell subsets, Cytokines, Free light chain, MxA, β2 microglobulin, Complement (C3 and C4), CRP, ESR
Measured: Week 0, 4, 8, 12, 24, 28, 32, 36 and 48
EQ-5D
Measured: Week 0, 12, 24, 36, 48
Work Participation and Activity Impairment questionnaire (WPAI)
Measured: Week 0, 12, 24, 36 and 48
Ultrasound of salivary glands
Measured: Week 0, 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Dr. H. Bootsma, University Medical Center Groningen
- Investigators
- H. Bootsma, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067910
- Sponsor's protocol ID
- IM101-473
- Acronym
- ASAPIII
- Status last verified
- Aug 2019
- First submitted
- 14 Feb 2014
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meiners PM, Vissink A, Kroese FG, Spijkervet FK, Smitt-Kamminga NS, Abdulahad WH, Bulthuis-Kuiper J, Brouwer E, Arends S, Bootsma H. Abatacept treatment reduces disease activity in early primary Sjogren's syndrome (open-label proof of concept ASAP study). Ann Rheum Dis. 2014 Jul;73(7):1393-6. doi: 10.1136/annrheumdis-2013-204653. Epub 2014 Jan 28.
PubMed 24473674Steinmetz TD, Verstappen GM, Schulz SR, de Wolff L, Wilbrink R, Visser A, Terpstra J, Bootsma H, Kroese FGM. Association of Circulating Antibody-Secreting Cell Maturity With Disease Features in Primary Sjogren's Syndrome. Arthritis Rheumatol. 2023 Jun;75(6):973-983. doi: 10.1002/art.42422. Epub 2023 Mar 22.
PubMed 36533856de Wolff L, van Nimwegen JF, Mossel E, van Zuiden GS, Stel AJ, Majoor KI, Olie L, Los LI, Vissink A, Spijkervet FKL, Verstappen GMPJ, Kroese FGM, Arends S, Bootsma H. Long-term abatacept treatment for 48 weeks in patients with primary Sjogren's syndrome: The open-label extension phase of the ASAP-III trial. Semin Arthritis Rheum. 2022 Apr;53:151955. doi: 10.1016/j.semarthrit.2022.151955. Epub 2022 Jan 10.
PubMed 35091325
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome (ASAP III Study = Abatacept Sjögren Active Patients Phase III Study)
- ClinicalTrials.gov ID
- NCT02067910
- Acronym / sponsor ID
- ASAPIII / IM101-473
- Conditions
- Sjögren's Syndrome
- Keywords
- Abatacept, Subcutaneous, Sjögren's syndrome, Treatment, Safety, Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Aug 2014
- Primary completion
- Feb 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Sjögren's syndrome (pSS) is a common chronic auto-immune disease, characterised by inflammation of the exocrine glands, resulting in progressive dryness of the eyes and the mouth. Furthermore, many patients experience extraglandular symptoms such as restricting fatigue. Currently, biological agents have been introduced in various systemic autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus. No biological agent has yet been approved for the treatment of pSS. In an open-label study, we have shown that abatacept treatment of pSS patients has promising results (Meiners et al., 2014). Therefore, the aim of this study is to evaluate efficacy and safety of subcutaneous abatacept treatment in pSS in a larger and randomized clinical trial.
Detailed description
Background: Primary Sjögren's syndrome (pSS) is a chronic inflammatory and lymphoproliferative disease with autoimmune features. pSS is characterised by a progressive lymphocytic infiltration of the exocrine glands, notably the lacrimal and salivary glands. The main clinical features are a progressive dryness of the eyes, mouth, vagina and skin. Furthermore, various extraglandular manifestations may develop of which restricting fatigue is the most common. Patients may be restricted in their activities and their participation in society, resulting in a reduced health-related quality of life and an impaired socioeconomic status. The latter results in lower employment rates and more disability as compared to the general population. The estimated prevalence of pSS in the general population is between 0.5-2%, which makes pSS, after rheumatoid arthritis (RA), the most common systemic autoimmune disease. Most of the traditional anti-rheumatic drugs used in RA and systemic lupus erythematosus have been tried in pSS with limited results. Currently, biological agents have been introduced in various systemic autoimmune diseases. These biological agents enhance or replace conventional immunosuppressive therapy. In contrast to RA and systemic lupus erythematosus (SLE), no biological agent has yet been approved for the treatment of pSS. Abatacept is a fully human soluble co-stimulation modulator that selectively targets the CD80/CD86:CD28 co-stimulatory signal required for full T-cell activation, and T cell dependent activation of B-cells. We have recently shown in a phase II open label study that Abatacept treatment of pSS patients has promising efficacy results, as reflected by a significant decrease in disease activity indices such as the EULAR Sjögrens Syndrome Disease Activity Index and Patient Reported Index (ESSDAI and ESSPRI) (Meiners et al., 2014). Importantly, we also have shown that Abatacept is safe and side effects are very limited in pSS patients. For these reasons a larger and randomized clinical trial with Abatacept is warranted.
Objective: Primary: to evaluate efficacy of weekly subcutaneous (SC) administration of Abatacept vs placebo on disease activity assessed with ESSDAI at in patients with pSS. Secondary: to assess efficacy of Abatacept on clinical, functional, laboratory, subjective, and histological parameters over 48 weeks in patients with pSS. To evaluate the safety of abatacept, by monitoring serious adverse events (SAE), adverse events (AE) related SAE and AE, treatment discontinuation related to SAE and AE, and lab abnormalities over 48 weeks in patients with pSS. Exploratory: to assess efficacy on laboratory parameters over 48 weeks in patients with pSS.
Study design: The first stage is a 24-week randomized, double-blind, placebo-controlled phase III study to assess the efficacy and safety of Abatacept (weekly SC administration of 125 mg Abatacept or placebo) in patients with pSS. The primary endpoint (ESSDAI) will be evaluated at 24 weeks. The second stage is composed of a 24-week open-label period in which both Abatacept and placebo treated patients will receive Abatacept for 24 weeks. The total study duration will be 48 weeks where after the study will be opened.
Study population: 88 adult pSS patients
Intervention: Weekly subcutaneous administration of 125 mg Abatacept up to 48 weeks.
Main endpoints: The primary endpoint is the difference in ESSDAI score between the Abatacept and the placebo group at 24 weeks. Secondary endpoints are clinical, functional, laboratory, subjective, and histological parameters and the prevalence of adverse events, treatment discontinuation and laboratory abnormalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abatacept SC | Active comparator | Drug: Abatacept SCWeekly subcutaneous administration of 125 mg Abatacept during 48 weeks |
| Placebo | Placebo comparator | Drug: Abatacept SCFirst phase: Weekly subcutaneous administration of placebo during 24 weeks. Second phase: Weekly subcutaneous administration of 125 mg Abatacept during 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed written informed consent
- ESSDAI ≥ 5
- Female or male ≥ 18 years
- pSS according to the American European Consensus Group (AECG) classification criteria (6)
- Disease duration ≤ 7 years at the moment of inclusion
Key exclusion criteria (32 listed)
- Presence of any other connective tissue disease.
- Flow rate of stimulated whole saliva \<0.05 ml/min in patients without extraglandular manifestations.
- Positive pregnancy test or breast-feeding women.
- Women with a child-bearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the entire study period.
- History of alcohol or drug abuse or current alcohol or drug 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 |
|---|---|---|
| Abatacept SCAlso: Subcutaneous Abatacept, OrenciaWeekly subcutaneous administration of 125 mg Abatacept | Drug | Abatacept SC, Placebo |
Primary outcome
ESSDAI
Time frame: 24 weeks
18 secondary outcomes
Safety parameters
Time frame: Week 4, 8, 12, 24, 28, 32, 36, 48
ESSDAI (at time-points other than 24 weeks)
Time frame: Week 0, 4, 8, 12, 28, 32, 36, 48
DAS28(CRP) and DAS28(ESR)
Time frame: Week 0, 4, 8, 12, 24, 28, 32, 36, 48
Corticosteroid dose (decrease, stable, increase)
Time frame: Week 0, 4, 8, 12, 24, 28, 32, 36, 48
Salivary gland function
Time frame: Week 0, 12, 24, 36 and 48
Tear gland function
Time frame: Week 0, 12, 24, 36 and 48
ESSPRI
Time frame: 0, 4, 8, 12, 24, 28, 32, 36, and 48.
Patient and Physician Global assessment of disease activity (patGDA, phyGDA)
Time frame: 0, 4, 8, 12, 24, 28, 32, 36, and 48
Multidimensional Fatigue Index (MFI)
Time frame: week 0, 12, 24, 36, and 48
Health related quality of life (Short Form-36; SF-36)
Time frame: week 0, 12, 24, 36, and 48
Patient Acceptable Symptom State (PASS)
Time frame: week 0, 12, 24, 36, and 48
Female Sexual Function Index (FSFI)
Time frame: week 0, 24 and 48
NRS score vaginal dryness
Time frame: Week 0, 24 and 48
Histological change in parotid gland
Time frame: Week 24
Laboratory immune markers
Time frame: Week 0, 4, 8, 12, 24, 28, 32, 36 and 48
EQ-5D
Time frame: Week 0, 12, 24, 36, 48
Work Participation and Activity Impairment questionnaire (WPAI)
Time frame: Week 0, 12, 24, 36 and 48
Ultrasound of salivary glands
Time frame: Week 0, 24 and 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background: PubMed 24473674Meiners PM, Vissink A, Kroese FG, Spijkervet FK, Smitt-Kamminga NS, Abdulahad WH, Bulthuis-Kuiper J, Brouwer E, Arends S, Bootsma H. Abatacept treatment reduces disease activity in early primary Sjogren's syndrome (open-label proof of concept ASAP study). Ann Rheum Dis. 2014 Jul;73(7):1393-6. doi: 10.1136/annrheumdis-2013-204653. Epub 2014 Jan 28.
- Derived from this study: PubMed 36533856Steinmetz TD, Verstappen GM, Schulz SR, de Wolff L, Wilbrink R, Visser A, Terpstra J, Bootsma H, Kroese FGM. Association of Circulating Antibody-Secreting Cell Maturity With Disease Features in Primary Sjogren's Syndrome. Arthritis Rheumatol. 2023 Jun;75(6):973-983. doi: 10.1002/art.42422. Epub 2023 Mar 22.
- Derived from this study: PubMed 35091325de Wolff L, van Nimwegen JF, Mossel E, van Zuiden GS, Stel AJ, Majoor KI, Olie L, Los LI, Vissink A, Spijkervet FKL, Verstappen GMPJ, Kroese FGM, Arends S, Bootsma H. Long-term abatacept treatment for 48 weeks in patients with primary Sjogren's syndrome: The open-label extension phase of the ASAP-III trial. Semin Arthritis Rheum. 2022 Apr;53:151955. doi: 10.1016/j.semarthrit.2022.151955. Epub 2022 Jan 10.
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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.
H. Bootsma, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abatacept SC in people with Sjögren's Syndrome, run by University Medical Center Groningen at 1 site in Netherlands.
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 8 inclusion and 32 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: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ESSDAI (time frame: 24 weeks). 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 NCT02067910, which also lists 3 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 28 Aug 2019.