Psoriatic ArthritisPhase 3GO-DACTNCT02065713
Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients
A Phase 3 study testing Golimumab and Methotrexate in people with Psoriatic Arthritis, run by Instituto de Medicina Molecular João Lobo Antunes at 1 site in Portugal.
Trial summary
Dactylitis is a poor prognostic factor in psoriatic arthritis (PsA) patients. The efficacy of synthetic or biologic disease modifying anti-rheumatic drugs (DMARDs) on dactylitis has not been previously studied in randomized controlled trials as a primary endpoint. 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?
- Golimumab and Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 sitePortugal
- Study dates
- Aug 2014to Jun 2017
- Phase
- Phase 3
- 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
- Each subject must be/have…..
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
- Age ≥ 18 years old, at baseline. A subject may be of both gender and any race/ethnicity.
- PsA diagnosis according to Classification of Psoriatic Arthritis (CASPAR) criteria, established at least 3 months prior to screening.
- Active psoriatic arthritis, at the time of entry into the study, defined by:
- ≥1 tender dactylitis, refractory to at least two systemic NSAIDs, at optimal dosage, for 3 months and at least one other site of active inflammation (peripheral joints, enthesis, spine, skin or nails).
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- Naïve to MTX therapy.
- Patients can have been previously treated with synthetic DMARDs (except MTX) or corticosteroids but must have withdrawn according to the following schedules:
- All synthetic DMARDs and oral corticosteroids withdrawn at least two weeks prior to screening or 5 half lives according, to what is longer, except for leflunomide.
- leflunomide ≥ 12 weeks or ≥ 2 weeks after standard cholestyramine or activated charcoal washout.
- Up to a maximum of two local corticosteroids injection are allowed, administrated, at least four weeks prior to screening (indication for local corticoids injection is dependent on expert opinion decision).
- NSAIDs (up to the maximum recommend dose) if the dose has been stable for at least 4 weeks prior to baseline and the patient is expected to remain on the baseline dose for the 6 months of the study.
- Female subjects or male subjects and his female sexual partner of childbearing potential must agree to use a medically accepted method of contraception prior to enrollment, while receiving protocol-specified medication and for 6 months after stopping the medication.
- Medically accepted methods of contraception include condoms (male or female) with a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), inert or copper containing IUD, hormone-releasing IUD, systemic hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal ligation). Other methods may be used as required by local legislation.
- Postmenopausal women are not required to use contraception (postmenopausal is defined as at least 12 consecutive months without a spontaneous menses).
Who cannot join
- A subject meeting any of the exclusion criteria listed below must be excluded from participating in the trial.
- The subject has ….
- Known or suspected allergy to trial product or related products.
- Body weight > 100 Kg.
- Current chronic inflammatory autoimmune disease other than PsA that might confound the evaluations of safety and toxicity such as, but not limited to, ankylosing spondylitis, rheumatoid arthritis, tophaceous gout, reactive arthritis, pseudogout, arthropathy of inflammatory bowel disease, systemic erythematosus lupus, mixed connective tissue disease, scleroderma or variants, and polymyositis
- Active current infection or history of recurrent or chronic bacterial, viral, fungal, mycobacterial or other infections, including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, HIV and herpes zoster.
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- History of severe systemic bacterial, viral or fungal infections within the past 12 months prior to screening.
- Past or current malignancy with the exception of:
- Adequately treated and cured basal cell carcinoma of the skin occurring more than 12 months prior to screening.
- Other cancer with a complete response duration of > 5 years or any period of time longer than that, respectively for those malignancies which are considered as resolved after passing this duration of response.
- Any clinically significant medical condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or patients safety and optimal participation in the trial such as, but not limited to:
- Moderate to severe heart failure (New York Heart Association class III/IV)
- Pre-existing central nervous system demyelinating disorders
- Increased liver enzymes: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN).
- Female subject must not be breast-feeding.
- Female subject must not be pregnant or intending to become pregnant.
- Any contra-indications to perform MRI:
- Patients who have a metal device affected by MRI
- Allergy or other contraindications to an i.v. injection of gadolinium-diethylenetriamine pentaacetic acid
- Claustrophobia sufficient to interfere with the patient undergoing the MRI scan.
- Previous treatment with tumor necrosis factor (TNF) blocking therapy or other biologic agents.
- Previous MTX therapy.
- Latent tuberculosis, in the absence of at least one month of isoniazid therapy, according to local guidelines.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Randomized, Double-blind, Parallel-group Study To Compare The Efficacy Of Golimumab In Combination With Methotrexate (MTX) Versus MTX Monotherapy, In Improving Dactylitis And Enthesitis, In MTX Naïve Psoriatic Arthritis Patients.
Dactylitis is a poor prognostic factor in psoriatic arthritis (PsA) patients. The efficacy of synthetic or biologic disease modifying anti-rheumatic drugs (DMARDs) on dactylitis has not been previously studied in randomized controlled trials as a primary endpoint.
In this investigator initiated clinical trial the investigators aim to test the hypothesis that the combination therapy of golimumab and methotrexate (MTX) will result in a significant improvement of dactylitis in comparison with MTX monotherapy, in MTX naïve psoriatic arthritis patients, at week 24. Similarly the efficacy on enthesitis, peripheral and axial involvement, skin and nail psoriasis, inflammation and damage of the feet and hands assessed by magnetic resonance imaging (MRI), composite indexes of disease activity, remission, function and quality of life will be determined.
Read more
This is a national multicentre, interventional, double-blinded, placebo-controlled, parallel design trial. 136 patients with active dactylitis, refractory to at least two systemic non-steroidal anti-inflammatory drugs (NSAIDs), at optimal dosage, for 3 months will be included and centrally randomized to golimumab in combination with MTX versus MTX monotherapy, in a 1:1 ratio. The study duration will be 24 weeks.
The investigators expect the results from this trial will contribute to a better definition of the treatment algorithm of PsA patients with dactylitis.
- Conditions
- Psoriatic Arthritis
- Being tested
- Golimumab, Methotrexate, Placebo
- Keywords
- Psoriatic arthritis, dactylitis, enthesitis
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolimumabDrug
Prefilled syringe with golimumab 50mg (Simponi®) administrated subcutaneously, once monthly, for 24 weeks.
MethotrexateDrug
MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
PlaceboDrug
The prefilled syringe with placebo will be administrated subcutaneously, once monthly, for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Golimumab in combination with methotrexate | Experimental | Golimumab 50mg, subcutaneous, once monthly, for 24 weeks, in combination with MTX.
MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity Receives: Drug: Golimumab; Drug: Methotrexate |
| Placebo in combination with methotrexate | Active comparator | MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity. Receives: Drug: Methotrexate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dactylitis Severity Score (DSS)
Changes from baseline in Dactylitis Severity Score at 24 weeks. Each digit with dactylitis was evaluated in a severity scale from 0 to 3 (0 = no dactylitis; 1 = mild dactylitis, 2 = moderate dactylitis, 3 = severe dactylitis). The total score is calculated as the sum of the individual digits dactylitis scores, ranging from a minimum 0 to a maximum of 60, with higher scores corresponding to worse severities.
Measured: From baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2017
- Study completionJun 2017
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 (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Medicina Molecular João Lobo Antunes
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Elsa Vieira de Sousa, Instituto de Medicina Molecular João Lobo Antunes
- Investigators
- Elsa Vieira de Sousa, MD, Principal investigator, Instituto de Medicina Molecular João Lobo Antunes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065713
- Sponsor's protocol ID
- IMM-50307
- Acronym
- GO-DACT
- Status last verified
- Oct 2020
- First submitted
- 17 Feb 2014
- Last updated
- 13 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Vieira-Sousa E, Alves P, Rodrigues AM, Teixeira F, Tavares-Costa J, Bernardo A, Pimenta S, Pimentel-Santos FM, Gomes JL, Aguiar R, Pinto P, Videira T, Catita C, Santos H, Borges J, Sequeira G, Ribeiro C, Teixeira L, Avila-Ribeiro P, Martins FM, Canhao H, McInnes IB, Ribeiro RM, Fonseca JE. GO-DACT: a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis. Ann Rheum Dis. 2020 Apr;79(4):490-498. doi: 10.1136/annrheumdis-2019-216500.
PubMed 32193187
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Double-blind, Parallel-group Study To Compare The Efficacy Of Golimumab In Combination With Methotrexate (MTX) Versus MTX Monotherapy, In Improving Dactylitis And Enthesitis, In MTX Naïve Psoriatic Arthritis Patients.
- ClinicalTrials.gov ID
- NCT02065713
- Acronym / sponsor ID
- GO-DACT / IMM-50307
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic arthritis, dactylitis, enthesitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Instituto de Medicina Molecular João Lobo AntunesUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Posted 5 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dactylitis is a poor prognostic factor in psoriatic arthritis (PsA) patients. The efficacy of synthetic or biologic disease modifying anti-rheumatic drugs (DMARDs) on dactylitis has not been previously studied in randomized controlled trials as a primary endpoint.
In this investigator initiated clinical trial the investigators aim to test the hypothesis that the combination therapy of golimumab and methotrexate (MTX) will result in a significant improvement of dactylitis in comparison with MTX monotherapy, in MTX naïve psoriatic arthritis patients, at week 24. Similarly the efficacy on enthesitis, peripheral and axial involvement, skin and nail psoriasis, inflammation and damage of the feet and hands assessed by magnetic resonance imaging (MRI), composite indexes of disease activity, remission, function and quality of life will be determined.
This is a national multicentre, interventional, double-blinded, placebo-controlled, parallel design trial. 136 patients with active dactylitis, refractory to at least two systemic non-steroidal anti-inflammatory drugs (NSAIDs), at optimal dosage, for 3 months will be included and centrally randomized to golimumab in combination with MTX versus MTX monotherapy, in a 1:1 ratio. The study duration will be 24 weeks.
The investigators expect the results from this trial will contribute to a better definition of the treatment algorithm of PsA patients with dactylitis.
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 |
|---|---|---|
| Golimumab in combination with methotrexate | Experimental | Drug: Golimumab, Drug: MethotrexateGolimumab 50mg, subcutaneous, once monthly, for 24 weeks, in combination with MTX. MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity |
| Placebo in combination with methotrexate | Active comparator | Drug: Methotrexate, Drug: PlaceboMTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Each subject must be/have…..
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
- Age ≥ 18 years old, at baseline. A subject may be of both gender and any race/ethnicity.
- PsA diagnosis according to Classification of Psoriatic Arthritis (CASPAR) criteria, established at least 3 months prior to screening.
- Active psoriatic arthritis, at the time of entry into the study, defined by:
Key exclusion criteria (23 listed)
- A subject meeting any of the exclusion criteria listed below must be excluded from participating in the trial.
- The subject has ….
- Known or suspected allergy to trial product or related products.
- Body weight > 100 Kg.
- Current chronic inflammatory autoimmune disease other than PsA that might confound the evaluations of safety and toxicity such as, but not limited to, ankylosing spondylitis, rheumatoid arthritis, tophaceous gout, reactive arthritis, pseudogout, arthropathy of inflammatory bowel disease, systemic erythematosus lupus, mixed connective tissue disease, scleroderma or variants, and polymyositis
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 |
|---|---|---|
| GolimumabPrefilled syringe with golimumab 50mg (Simponi®) administrated subcutaneously, once monthly, for 24 weeks. | Drug | Golimumab in combination with methotrexate |
| MethotrexateMTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity | Drug | Golimumab in combination with methotrexate, Placebo in combination with methotrexate |
| PlaceboThe prefilled syringe with placebo will be administrated subcutaneously, once monthly, for 24 weeks. | Drug | Placebo in combination with methotrexate |
Primary outcome
Dactylitis Severity Score (DSS)
Time frame: From baseline to week 24
Changes from baseline in Dactylitis Severity Score at 24 weeks. Each digit with dactylitis was evaluated in a severity scale from 0 to 3 (0 = no dactylitis; 1 = mild dactylitis, 2 = moderate dactylitis, 3 = severe dactylitis). The total score is calculated as the sum of the individual digits dactylitis scores, ranging from a minimum 0 to a maximum of 60, with higher scores corresponding to worse severities.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32193187Vieira-Sousa E, Alves P, Rodrigues AM, Teixeira F, Tavares-Costa J, Bernardo A, Pimenta S, Pimentel-Santos FM, Gomes JL, Aguiar R, Pinto P, Videira T, Catita C, Santos H, Borges J, Sequeira G, Ribeiro C, Teixeira L, Avila-Ribeiro P, Martins FM, Canhao H, McInnes IB, Ribeiro RM, Fonseca JE. GO-DACT: a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis. Ann Rheum Dis. 2020 Apr;79(4):490-498. doi: 10.1136/annrheumdis-2019-216500.
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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.
Elsa Vieira de Sousa, MD principal investigator
Instituto de Medicina Molecular João Lobo Antunes
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 Golimumab and Methotrexate in people with Psoriatic Arthritis, run by Instituto de Medicina Molecular João Lobo Antunes at 1 site in Portugal.
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 15 inclusion and 23 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 13 Nov 2020. 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 Portugal. 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 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?
Yes. Results are posted in the registry (first posted 5 Oct 2020). 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?
Dactylitis Severity Score (DSS) (time frame: From baseline to week 24). 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 NCT02065713, 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 13 Nov 2020.