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Psoriatic ArthritisPhase 3NCT01871649

Initial Treatment With Golimumab in Early PsA

A Phase 3 study testing golimumab and methotrexate in people with Psoriatic Arthritis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators will perform a 22-week randomized, double-blind, placebo-controlled trial of golimumab + methotrexate (MTX) versus methotrexate alone in methotrexate-naïve patients with Psoriatic Arthritis (PsA). Afterwards, a 28 week open label phase with methotrexate alone is started. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Psoriatic Arthritis
What is being tested?
golimumab and methotrexate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
2 sitesNetherlands
Study dates
Aug 2013to Nov 2018
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Prior to any study procedure, voluntary written informed consent must be obtained, after the nature and purpose of this study were explained
  • Patients should be between 18 and 70 years of age at time of consent
  • Patients must have a diagnosis of PsA according to the Classification for psoriatic Arthritis (CASPAR) classification criteria (see Appendix 1).
  • The patient must have an active disease as defined by 3 swollen and 3 tender joints.
  • The use of a stable dose of concomitant nonsteroidal antiinflammatory drug (NSAIDs) and/or corticosteroids is allowed. The dose of corticosteroids should not exceed a prednisone equivalent of 10 mg/day and must be stable for at least 4 weeks prior to baseline. The dose of concomitant NSAIDs and corticosteroids should be kept stable during the whole study period.
  • Patients are considered to be in generally good health based upon the result of a medical history, physical examination, laboratory profile, chest X-ray and electrocardiography (ECG).

Who cannot join

  • Patient has a concomitant rheumatic condition other than PsA
  • Positivity for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti CCP) antibodies (ACPA)
  • Current or previous use of methotrexate
  • Current use of other Disease Modifying Antirheumatic drug (DMARDs) (sulphasalazine or leflunomide).
  • Prior use of other DMARDs (sulphasalazine or leflunomide) within 3 months before baseline.
  • Current or previous use of biologicals, including Tumor Necrosis Factor (TNF) blocking therapy
Show all 15Show fewer
  • Patient has active tuberculosis. A purified protein derivative (PPD) skin test and chest X-ray at screening should be negative (in case of latent tuberculosis, a patient may enter the study if prophylaxis with isoniazide is begun prior to administration of study medication). If a patient has an adequately treated tuberculosis in the past, he/she may enter the trial.
  • Patient has received an intra-articular injection with corticosteroids within 4 weeks prior to baseline.
  • Patient has a malignancy (other than basal cell carcinoma of the skin) in the past 5 years
  • Patients has a recent history of (or persistent) infection requiring hospitalization or antibiotic treatment within 4 weeks of baseline Patient has a significant history of cardiac, pulmonary, renal (glomerular filtration rate <40ml/min), hepatic (liver cirrhosis), hematological, neurological, metabolic or any other disease that may affect his/her participation in this study. This should be decided by the opinion of the investigator.
  • All females of childbearing potential must use appropriate contraception, be postmenopausal or surgically sterile. A urine pregnancy-test beta-human chorion gonadotropin (Beta-HCG) will be performed at screening and has to be negative.
  • Subject is pregnant or a breastfeeding woman
  • Liver disease or liver injury as indicated by abnormal liver function tests such as Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), gammaglutamyl transpeptidase (GGT), alkaline phosphatase, or serum bilirubin. The Investigator should be guided by the following criteria: Any single parameter may not exceed 2 x upper limit of normal (ULN).
  • A single parameter elevated up to and including 2 x ULN should be rechecked once more if elevation levels are found clinically relevant according to the physician, at least prior to enrolment.
  • Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Reade

    Amsterdam, North Holland, 1056 AB

  • Academic Medical Center/University of Amsterdam

    Amsterdam, North Holland, 1105 AZ

Other trials in Netherlands

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Trial of Golimumab+Methotrexate Versus Methotrexate Alone in Methotrexate-naïve Patients With Psoriatic Arthritis

The investigators will perform a 22-week randomized, double-blind, placebo-controlled trial of golimumab + methotrexate (MTX) versus methotrexate alone in methotrexate-naïve patients with Psoriatic Arthritis (PsA). Afterwards, a 28 week open label phase with methotrexate alone is started. Golimumab will be discontinued.

Hypotheses:

Read more

First, the investigators hypothesize that initiation of a combination therapy with golimumab + MTX will be safe and superior to MTX alone in MTX-naïve PsA patients, as assessed by the percentage of patients achieving Disease Activity Score (the investigators hypothesize that more patients with the early combination treatment will respond (according to Disease Activity Score (DAS), American college of Rheumatology (ACR), or Psoriatic Arthritis Response Criteria (PsARC) responses) and achieve a state of Low Disease Activity (LDA) or Minimal Disease Activity (MDA) than patients on MTX alone.

Third, the investigators hypothesize that a significant proportion of the patients will continue to benefit from this early aggressive treatment initiation even after stopping golimumab treatment.

Being tested
golimumab, methotrexate
Keywords
psoriatic arthritis, golimumab, methotrexate, minimal disease activity, safety, withdrawal
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

    Also called simponi

    golimumab 50mg subcutaneous injections (in combination with methotrexate), once a month, for a period of 22 weeks

  • methotrexateDrug

    Methotrexate will be started at a dosage of 15 mg/week orally and, if well tolerated, increased to 20mg/week at week 4 and 25mg/week at week 8 of the trial. If well tolerated, the maximum dose of 25 mg/week will be sustained until end of study (week 50). Folic acid 5 mg/week will be administered orally one day after the MTX intake.

Study groups in NCT01871649
Study groupRoleWhat they receive
methotrexateActive comparatormethotrexate is the active comparator, it will be compared to golimumab + methotrexate
Receives: Drug: methotrexate
golimumab and methotrexateExperimentalThe combination of golimumab en methotrexate will be compared to methotrexate alone.
Receives: Drug: golimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients achieving DAS remission response criteria

    1. To demonstrate that golimumab + MTX is superior to MTX alone in achieving DAS remission in MTX naïve PsA patients at week 22

    DAS = Disease activity score, remission is defined as a DAS < 1.6

    Measured: week 22

  2. Number of Participants with Adverse Events

    Number of patients with(severe) adverse events (and type) during the study period.

    Safety will be monitored during the study period by laboratory tests and physical examination.

    Measured: week 22

Secondary outcomes (1)

  1. Number of patients fulfilling Minimal Disease activity criteria and other outcome measurements

    To demonstrate that golimumab + MTX is superior to MTX alone as assessed by DAS, ACR and PsARC responses, as well as by achievement of low disease activity (LDA, as defined by DAS<2.4) and minimal disease activity (MDA, as defined by Coates et al, Ann Rheum Dis 2010). Also the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) score and Psoriasis Area Severity Index (PASI) score will be determined in MTX naïve PsA patients at week 22.

    Measured: week 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionNov 2018
  4. Study completionNov 2018

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01871649
Sponsor's protocol ID
AMC_ 42670_PsA_Golimumab
Status last verified
Nov 2018
First submitted
7 Jan 2013
Last updated
26 Nov 2018
Results posted
No
Data monitoring committee
No

Publications

  • de Jong HMY, van Mens LJJ, Nurmohamed MT, Kok MR, van Kuijk AWR, Baeten DLP, van de Sande MGH. Sustained remission with methotrexate monotherapy after 22-week induction treatment with TNF-alpha inhibitor and methotrexate in early psoriatic arthritis: an open-label extension of a randomized placebo-controlled trial. Arthritis Res Ther. 2019 Sep 14;21(1):208. doi: 10.1186/s13075-019-1998-4.

    PubMed 31521192

  • van Mens LJJ, de Jong HM, Fluri I, Nurmohamed MT, van de Sande MGH, Kok M, van Kuijk AWR, Baeten D. Achieving remission in psoriatic arthritis by early initiation of TNF inhibition: a double-blind, randomised, placebo-controlled trial of golimumab plus methotrexate versus placebo plus methotrexate. Ann Rheum Dis. 2019 May;78(5):610-616. doi: 10.1136/annrheumdis-2018-214746. Epub 2019 Feb 26.

    PubMed 30808625

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 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites 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 6 inclusion and 15 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 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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?

Percentage of patients achieving DAS remission response criteria (time frame: week 22). 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 NCT01871649, 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 26 Nov 2018.

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