Palindromic Rheumatism, WristPhase 4PALABANCT03669367
EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)
A Phase 4 study testing Abatacept Injection and hydroxycloroquina in people with Palindromic Rheumatism, Wrist, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial summary
The main objective of this trial is to test the hypothesis that abatacept can reduce the progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism compared with patients treated with hydroxychloroquine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palindromic Rheumatism, Wrist
- What is being tested?
- Abatacept Injection and hydroxycloroquina
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jun 2019to 30 Sep 2024
- Phase
- Phase 4
- 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
- Patients with PR according to Guerne and Weissman modified criteria (18) and with:
- Disease evolution > 3 months and < 24 months.
- ACPA positivity proven by ELISA test or chemiluminescence (CCP2) and/or Rheumatoid factor positivity (ELISA, nephelometry or chemiluminescence).
- Greater than 18 years of age.
Who cannot join
- Persistent arthritis: (involvement in one or more joints > 1 week).
- Criteria of other rheumatic diseases (RA, SLE, etc.).
- Evidence of radiographic damage (join erosions).
- Absence of ACPA or RF.
- Contraindication or intolerance to study drugs (abatacept or hydroxychloroquine).
- Steroid treatment one month before study entry.
- Previous antitrheumatic therapy with synthetic DMARDS (methotrexate, leflunomide, sulfasalazine, cyclosporine, antimalarials.) or biological DMARDs.
- Pregnant women or who want to be pregnant during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA)
The main objective of this trial is to test the hypothesis that abatacept can reduce the progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism compared with patients treated with hydroxychloroquine.
Read the detailed description
The main objective of this trial is to test the hypothesis that abatacept can reduce the progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism compared with patients treated with hydroxychloroquine.
- Conditions
- Palindromic Rheumatism, Wrist
- Being tested
- Abatacept Injection, hydroxycloroquina
- Medical subject headings
- Palindromic rheumatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abatacept InjectionDrug
Also called ORENCIA
Abatacept subcutaneous in monotherapy 125 mg/week during the first year (12 months). Abtacept subcutaneus in monotherapy 125 mg/2weeks during the second year.
hydroxycloroquinaDrug
oral hydroxycloroquina 5 mg/Kg/day for 2 years (0-48 months)
| Study group | Role | What they receive |
|---|---|---|
| abatacept | Experimental | abatacept monotherapy (subcutaneous route).: 125 mg solution for injection in pre-filled syringe. In the first year (0-12 months) at a a dose of 125 mg per week (full dose) and in the second year (12-24 months) at a dose of 125 mg every other week (q2w) (optimized dose) injection) - 125 mg x week - subcutaneous use. Receives: Drug: Abatacept Injection |
| hydroxycloroquina | Active comparator | Hydroxyclorquina (Coated tablet)- (5 mg/Kg/day) monotherapy for 2 years (0-48 months) Receives: Drug: hydroxycloroquina |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective of this trial is to test abatacept efficacy
number of participants developed persistent arthritis fulfilling criteria of Rheumatoid Arthritis according to EULAR/ACR 2010 classification criteria persistent arthritis (RA criteria)
Measured: At any time during the follow-up (up to 24 months)
Secondary outcomes (2)
Number of participants with treatment-related adverse events as asesed
Number of participants with treatment-related adverse events as asesed
Measured: At any time during the follow-up (up to 24 months)
number of participants with titles positives on serum ACPA.(anti-CarP antibodies)
number of participants with titles positives on serum ACPA.(anti-CarP antibodies)
Measured: At any time during the follow-up (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start3 Jun 2019
- Primary completion30 Jun 2022
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Palindromic Rheumatism, WristStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- National multi-center study, open, controlled and randomized
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669367
- Sponsor's protocol ID
- PALABA 2017-004543-20
- Acronym
- PALABA
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2018
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sanmarti R, Perez-Garcia C, de-Toro FJ, Salvador G, Escudero-Contreras A, Cuervo A, Graell E, Reina D, Kanterewicz E, Corominas H, Urionaguena-Onaindia I, Lopez-Lasanta M, Olive A, Sala-Gomez M, Frade-Sosa B, Morla-Novell RM, Polino L, Meraz-Ostiz JA, Oreiro N, Blanco FJ, Perez-Nadales I, Ortega-Castro R, Busquets-Perez N, Gomez-Centeno AD, Camacho O, Rodriguez-Cros JR, Millan-Arciniegas AM, Garcia-Llorente JF, Borrell H, Prior-Espanol A, Castell-Quinones S, Cruceta A, Bonfill E, Domenech-Gomez G, Roca-Fabregas A, Rios J, Tobalina-Maestre L, Gomara MJ, Haro I. Abatacept versus hydroxychloroquine for prevention of rheumatoid arthritis in individuals with palindromic rheumatism: a randomized open-label trial. Nat Med. 2026 Jul;32(7):2610-2618. doi: 10.1038/s41591-026-04395-6. Epub 2026 May 14.
PubMed 42135532
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA)
- ClinicalTrials.gov ID
- NCT03669367
- Acronym / sponsor ID
- PALABA / PALABA 2017-004543-20
- Conditions
- Palindromic Rheumatism, Wrist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 13 Sep 2018 (actual)
- 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.
The main objective of this trial is to test the hypothesis that abatacept can reduce the progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism compared with patients treated with hydroxychloroquine.
Detailed description
The main objective of this trial is to test the hypothesis that abatacept can reduce the progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism compared with patients treated with hydroxychloroquine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- National multi-center study, open, controlled and randomized
| Arm | Type | Receives |
|---|---|---|
| abatacept | Experimental | Drug: Abatacept Injectionabatacept monotherapy (subcutaneous route).: 125 mg solution for injection in pre-filled syringe. In the first year (0-12 months) at a a dose of 125 mg per week (full dose) and in the second year (12-24 months) at a dose of 125 mg every other week (q2w) (optimized dose) injection) - 125 mg x week - subcutaneous use. |
| hydroxycloroquina | Active comparator | Drug: hydroxycloroquinaHydroxyclorquina (Coated tablet)- (5 mg/Kg/day) monotherapy for 2 years (0-48 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with PR according to Guerne and Weissman modified criteria (18) and with:
- Disease evolution > 3 months and < 24 months.
- ACPA positivity proven by ELISA test or chemiluminescence (CCP2) and/or Rheumatoid factor positivity (ELISA, nephelometry or chemiluminescence).
- Greater than 18 years of age.
Key exclusion criteria (8 listed)
- Persistent arthritis: (involvement in one or more joints > 1 week).
- Criteria of other rheumatic diseases (RA, SLE, etc.).
- Evidence of radiographic damage (join erosions).
- Absence of ACPA or RF.
- Contraindication or intolerance to study drugs (abatacept or hydroxychloroquine).
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 InjectionAlso: ORENCIAAbatacept subcutaneous in monotherapy 125 mg/week during the first year (12 months). Abtacept subcutaneus in monotherapy 125 mg/2weeks during the second year. | Drug | abatacept |
| hydroxycloroquinaoral hydroxycloroquina 5 mg/Kg/day for 2 years (0-48 months) | Drug | hydroxycloroquina |
Primary outcome
The main objective of this trial is to test abatacept efficacy
Time frame: At any time during the follow-up (up to 24 months)
number of participants developed persistent arthritis fulfilling criteria of Rheumatoid Arthritis according to EULAR/ACR 2010 classification criteria persistent arthritis (RA criteria)
2 secondary outcomes
Number of participants with treatment-related adverse events as asesed
Time frame: At any time during the follow-up (up to 24 months)
number of participants with titles positives on serum ACPA.(anti-CarP antibodies)
Time frame: At any time during the follow-up (up to 24 months)
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 26 Feb 2025.
- Derived from this study: PubMed 42135532Sanmarti R, Perez-Garcia C, de-Toro FJ, Salvador G, Escudero-Contreras A, Cuervo A, Graell E, Reina D, Kanterewicz E, Corominas H, Urionaguena-Onaindia I, Lopez-Lasanta M, Olive A, Sala-Gomez M, Frade-Sosa B, Morla-Novell RM, Polino L, Meraz-Ostiz JA, Oreiro N, Blanco FJ, Perez-Nadales I, Ortega-Castro R, Busquets-Perez N, Gomez-Centeno AD, Camacho O, Rodriguez-Cros JR, Millan-Arciniegas AM, Garcia-Llorente JF, Borrell H, Prior-Espanol A, Castell-Quinones S, Cruceta A, Bonfill E, Domenech-Gomez G, Roca-Fabregas A, Rios J, Tobalina-Maestre L, Gomara MJ, Haro I. Abatacept versus hydroxychloroquine for prevention of rheumatoid arthritis in individuals with palindromic rheumatism: a randomized open-label trial. Nat Med. 2026 Jul;32(7):2610-2618. doi: 10.1038/s41591-026-04395-6. Epub 2026 May 14.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abatacept Injection and hydroxycloroquina in people with Palindromic Rheumatism, Wrist, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
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 4 inclusion and 8 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 26 Feb 2025. 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 Spain. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The main objective of this trial is to test abatacept efficacy (time frame: At any time during the follow-up (up to 24 months)). 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 NCT03669367, which also lists 1 linked publication.
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 26 Feb 2025.