NCT00975130: GO-MORE

An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2)

Completed Phase 3 Results posted Last updated 16 March 2017

What this trial tests

Phase 3 trial testing SC golimumab in Arthritis, Rheumatoid in 3,366 participants. Completed in 1 February 2012.

Timeline

1 September 2009

Primary endpoint
1 August 2011

1 February 2012

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	3,366
Start date	1 September 2009
Primary completion	1 August 2011
Estimated completion	1 February 2012

Drugs / interventions tested

• SC golimumab — full drug profile →
• IV golimumab — full drug profile →

Conditions studied

• Arthritis, Rheumatoid — all drugs for Arthritis, Rheumatoid →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Arthritis, Rheumatoid. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6
  Time frame: Month 6
  EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease \>1.2 units and a final DAS28-ESR \< 3.2 units, while a moderate response was defined as a decrease \> 1.2 units and final DAS28-ESR \>= 3.2 units, OR a decrease of 0.
• Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12
  Time frame: Start of Month 11, End of Month 12
  The number of participants experiencing DAS28-ESR remission was evaluated at the start of study Month 11 and the end of study Month 12. The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR \<2.6.

Sponsor's own description

Part 1 of this trial will assess the safety and effectiveness of subcutaneous (SC) golimumab administered by autoinjector once monthly, when combined with different disease-modifying antirheumatic drug (DMARD) regimens used in daily rheumatology practice. Subsequently, Part 2 will study if a strategy of intravenous (IV) golimumab to induce remission followed by SC golimumab to retain remission is superior to continuing a SC regimen.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Golimumab for Rheumatoid Arthritis.
   Pelechas E, Voulgari PV, Drosos AA. · · 2019 · cited 32× · PMID 30897745 · DOI 10.3390/jcm8030387
2. Prediction of remission and low disease activity in disease-modifying anti-rheumatic drug-refractory patients with rheumatoid arthritis treated with golimumab.
   Vastesaeger N, Kutzbach AG, Amital H, Pavelka K, et al · · 2016 · cited 19× · PMID 27114562 · DOI 10.1093/rheumatology/kew179
3. Efficacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs: results of the GO-MORE study.
   Combe B, Dasgupta B, Louw I, Pal S, et al · · 2014 · cited 15× · PMID 23740226 · DOI 10.1136/annrheumdis-2013-203229
4. Regional differences in baseline disease activity and remission rates following golimumab treatment for RA: results from the GO-MORE trial.
   Durez P, Pavelka K, Lazaro MA, Garcia-Kutzbach A, et al · · 2018 · cited 1× · PMID 29611083 · DOI 10.1007/s10067-018-4074-6
5. Efficacy of golimumab in Belgian patients with active rheumatoid arthritis despite treatment with non-biologic disease-modifying anti-rheumatic drugs: sub-analysis of the GO-MORE study.
   Durez P, Vanthuyne M, Soyfoo MS, Hoffman I, et al · · 2017 · cited 1× · PMID 28431485 · DOI 10.1080/17843286.2017.1314079