A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

20 Oct 2025 → ongoing

Decision date (initial)

2026-01-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the safety and efficacy of monotherapy and/or combination therapy for the treatment of moderately to severely active Rheumatoid arthritis.

Secondary objectives 1

1. To evaluate the pharmacokinetics, pharmacodynamics, and immunogenicity (if applicable) of monotherapy and/or combination therapy for the treatment of moderately to severely active rheumatoid arthritis.

Conditions and MedDRA coding

Rheumatoid Arthritis

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. At any time prior to the Screening Visit, participant must have been treated for > or = 3 months with at least 1 biologic/targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) therapy but continued to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. The maximum cap for prior use of b/ tsDMARD is 2.
2. Participant must be on a stable dose of methotrexate (MTX)

Exclusion criteria 2

1. Participant is taking nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, low-potency opioids (tramadol, codeine, hydrocodone, alone or in combination with acetaminophen), unless they have been on stable doses for ≥ 1 week prior to Baseline Visit; and/or oral corticosteroids (equivalent to ≤ 10 mg/day of prednisone), or inhaled corticosteroids for stable medical conditions unless they have been on stable doses for ≥ 4 weeks prior to Baseline Visit.
2. History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than rheumatoid arthritis.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12

Secondary endpoints 7

1. Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
2. Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
3. Percentage Of Participants Achieving Low Disease Activity (LDA) per Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP) at Week 12
4. Percentage Of Participants Achieving Clinical Remission (CR) per DAS28 (CRP) at Week 12
5. Change from Baseline in DAS28 (CRP) at Week 12
6. Percentage Of Participants Achieving LDA per Clinical Disease Activity Index (CDAI) at Week 12
7. Percentage Of Participants Achieving CR per CDAI at Week 12

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 6

Locations

6 EU/EEA countries · 33 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 32 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

11 submissions — initial application plus substantial / non-substantial modifications