Phase III Trial of Adalimumab in pSpA

The ABILITY-2 study, described previously (ClinicalTrials.gov, NCT01064856),2 (link) was a phase III, multicentre, randomised, double-blind, placebo-controlled trial in patients with active non-psoriatic pSpA. Patients were randomised 1:1 to receive adalimumab (AbbVie, North Chicago, Illinois, USA) 40 mg every other week or placebo during a 12-week double-blind period,2 (link) followed by an open-label period of up to 3 years of adalimumab treatment. Eligible patients were aged ≥18 years, fulfilled the ASAS criteria for pSpA1 (link) and had pSpA symptoms for ≥3 months before the study baseline visit. Patients had active disease, a score ≥40 mm on a 0–100 mm visual analogue scale (VAS) for Patient Global Assessment of disease activity (PtGA) and Patient Global Assessment of pain (PtGA-pain) and an inadequate response to ≥2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or contraindication for NSAIDs. The study was performed in accordance with the International Conference on Harmonisation Guidelines for Good Clinical Practice and the Declaration of Helsinki.

Partial Protocol Preview
This section provides a glimpse into the protocol.
The remaining content is hidden due to licensing restrictions, but the full text is available at the following link: Access Free Full Text.

Van den Bosch F., Mease P.J., Sieper J., Baeten D.L., Xia Y., Chen S., Pangan A.L, & Song I.H. (2018). Long-term efficacy and predictors of remission following adalimumab treatment in peripheral spondyloarthritis: 3-year results from ABILITY-2. RMD Open, 4(1), e000566.

Publication 2018

adalimumab

Adalimumab Asas Conference Non steroidal anti inflammatory drugs Pain Pain assessment Patient Placebo Visual analogue scale

Corresponding Organization : University of Washington

Other organizations : Ghent University Hospital, Charité - Universitätsmedizin Berlin, University of Amsterdam, University of Illinois at Chicago, AbbVie (United States)

Top 5 similar protocols

Variable analysis

independent variables

Adalimumab 40 mg every other week
Placebo

dependent variables

Patient Global Assessment of disease activity (PtGA)
Patient Global Assessment of pain (PtGA-pain)

control variables

Patients aged ≥18 years
Patients fulfilling the ASAS criteria for pSpA
Patients with pSpA symptoms for ≥3 months before the study baseline visit
Patients with active disease (score ≥40 mm on a 0–100 mm visual analogue scale for PtGA and PtGA-pain)
Patients with an inadequate response to ≥2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or contraindication for NSAIDs

controls

Placebo

Annotations

Based on most similar protocols

Etiam vel ipsum. Morbi facilisis vestibulum nisl. Praesent cursus laoreet felis. Integer adipiscing pretium orci. Nulla facilisi. Quisque posuere bibendum purus. Nulla quam mauris, cursus eget, convallis ac, molestie non, enim. Aliquam congue. Quisque sagittis nonummy sapien. Proin molestie sem vitae urna. Maecenas lorem.

As authors may omit details in methods from publication, our AI will look for missing critical information across the 5 most similar protocols.

About PubCompare

Our mission is to provide scientists with the largest repository of trustworthy protocols and intelligent analytical tools, thereby offering them extensive information to design robust protocols aimed at minimizing the risk of failures.

We believe that the most crucial aspect is to grant scientists access to a wide range of reliable sources and new useful tools that surpass human capabilities.

However, we trust in allowing scientists to determine how to construct their own protocols based on this information, as they are the experts in their field.

Ready to get started?

Revolutionizing how scientists
search and build protocols!