NCT01752855

A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab

Completed Phase 2 Results posted Last updated 22 October 2014

What this trial tests

Phase 2 trial testing New formulation adalimumab in Rheumatoid Arthritis in 88 participants. Completed in 1 October 2013.

Timeline

1 December 2012

Primary endpoint
1 October 2013

1 October 2013

Quick facts

Lead sponsor	AbbVie (prior sponsor, Abbott)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	88
Start date	1 December 2012
Primary completion	1 October 2013
Estimated completion	1 October 2013
Sites	20 locations across United States, Belgium, Czechia, Germany, Puerto Rico, Romania, Slovakia

Drugs / interventions tested

• New formulation adalimumab — full drug profile →

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

AbbVie (prior sponsor, Abbott) — full company profile →

Who can join

18 and older, any sex, with Rheumatoid Arthritis. 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.

• Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48
  Time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
  The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 in
• Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48
  Time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
  American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of diseas
• Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48
  Time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
  American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met: * ≥ 50% improvement in tender joint count; * ≥ 50% improvement in swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of diseas
• Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48
  Time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
  The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without

Sponsor's own description

A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed new adalimumab formulation.

Publications & conference data

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

1. Biologics or tofacitinib for people with rheumatoid arthritis naive to methotrexate: a systematic review and network meta-analysis.
   Singh JA, Hossain A, Mudano AS, Tanjong Ghogomu E, et al · · 2017 · cited 44× · PMID 28481462 · DOI 10.1002/14651858.cd012657
2. Biologics or tofacitinib for people with rheumatoid arthritis unsuccessfully treated with biologics: a systematic review and network meta-analysis.
   Singh JA, Hossain A, Tanjong Ghogomu E, Mudano AS, et al · · 2017 · cited 38× · PMID 28282491 · DOI 10.1002/14651858.cd012591