A Phase 2a Multicenter, Randomized, Double Blind, Parallel, Proof of concept Study Evaluating the Efficacy and Safety of Nipocalimab and Certolizumab Combination Therapy in Participants with Active Rheumatoid Arthritis despite Prior Treatment with Advanced Therapies (bDMARD or tsDMARD)

2023-504045-31-00 Protocol 80202125ARA2002 Therapeutic exploratory (Phase II) Ended

Start 8 Feb 2024 · End 30 Oct 2024 · Status Ended · 3 EU/EEA countries · 10 sites · Protocol 80202125ARA2002

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ended
Participants planned 90
Countries 3
Sites 10

Rheumatoid Arthritis

To evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy in participants with moderately to severely active RA despite ≥1 advanced therapy (bDMARDs or tsDMARDs).

Key facts

Sponsor
Janssen - Cilag International
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Immune System Diseases [C20]
Trial duration
8 Feb 2024 → 30 Oct 2024
Decision date (initial)
2023-10-09
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Safety, Others, Pharmacogenomic, Pharmacodynamic

To evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy in participants with moderately to severely active RA despite ≥1 advanced therapy (bDMARDs or tsDMARDs).

Conditions and MedDRA coding

Rheumatoid Arthritis

VersionLevelCodeTermSystem organ class
21.0 PT 10039073 Rheumatoid arthritis 100000004859

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
Yes
IPD plan description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. 18 to 75 years of age, inclusive
  2. Medically stable on the basis of clinical laboratory tests performed at screening
  3. Diagnosis of RA and meeting the 2010 ACR/ EULAR Criteria for RA for at least 12 weeks before screening
  4. Has moderate to severe active RA as defined by persistent disease activity with at least 6 of 66 swollen joints and 6 of 68 tender joints at the time of screening and at baseline
  5. Is positive for ACPA or RF by the central laboratory at the time of screening

Exclusion criteria 5

  1. Has a diagnosed or reported history or current signs or symptoms indicating severe, progressive, or uncontrolled hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (except RA), psychiatric, or metabolic disturbances, which are detected at screening assessments (ie, laboratory testing, physical examination, vital signs) or reported by the participant
  2. Has other inflammatory diseases that might confound the evaluation of benefit in this study, including but not limited to Crohn’s disease, ulcerative colitis, interstitial lung disease, ankylosing spondylitis, psoriatic arthritis, primary Sjogren’s syndrome, SLE, and Lyme disease
  3. Has a history of any clinically significant adverse reaction to therapeutic proteins (eg, mABs), including, but not limited to, allergic reactions or severe immediate hypersensitivity reactions, such as anaphylaxis
  4. Allergies, hypersensitivity, or intolerance to investigational medicinal products
  5. Has a diagnosis of congestive heart failure including medically controlled, asymptomatic congestive heart failure

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Change from baseline in DAS28-CRP at Week 12

Investigational products

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

Test 2

JNJ-80202135

PRD9995561 · Product

Active substance
Nipocalimab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
22 Week(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

Cimzia 200 mg solution for injection in pre-filled syringe

PRD326002 · Product

Active substance
Certolizumab Pegol
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
22 Week(s)
Authorisation status
Authorised
ATC code
L04AB05 — -
Marketing authorisation
EU/1/09/544/002
MA holder
UCB PHARMA S.A. (ANDERL BE)
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Saline, 0.9% Sodium Chloride Solution for Injection

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Auxiliary 11

—

SCP26549405 · ATC

Route of administration
ORAL
Max daily dose
1 mg milligram(s)
Max total dose
252 mg milligram(s)
Max treatment duration
36 Week(s)
Authorisation status
Authorised
ATC code
V03AF03 — CALCIUM FOLINATE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

N02B · Product

Pharmaceutical form
-
Route of administration
ORAL
Max daily dose
3 g gram(s)
Max total dose
756 g gram(s)
Max treatment duration
36 Week(s)
Authorisation status
Authorised
ATC code
N02B — OTHER ANALGESICS AND ANTIPYRETICS
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Hydroxychloroquine Sulfate

SCP750999 · ATC

Active substance
Hydroxychloroquine Sulfate
Substance synonyms
2-[4-[(7-CHLOROQUINOLIN-4-YL)AMINO]PENTYL-ETHYL-AMINO]ETHANOL, SULFURIC ACID, HYDROXYCHLOROQUINE SULPHATE
Route of administration
ORAL
Max daily dose
400 mg milligram(s)
Max total dose
100 g gram(s)
Max treatment duration
36 Week(s)
Authorisation status
Authorised
ATC code
P01BA02 — HYDROXYCHLOROQUINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

H02AB · Product

Pharmaceutical form
PHF00231MIG
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
2520 mg milligram(s)
Max treatment duration
36 Week(s)
Authorisation status
Authorised
ATC code
H02AB — GLUCOCORTICOIDS
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Leflunomide

SCP138875 · ATC

Active substance
Leflunomide
Route of administration
ORAL
Max daily dose
20 mg milligram(s)
Max total dose
5040 mg milligram(s)
Max treatment duration
36 Week(s)
Authorisation status
Authorised
ATC code
L04AA13 — LEFLUNOMIDE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Calcium Folinate

SCP776846 · ATC

Active substance
Calcium Folinate
Substance synonyms
LEUCOVORIN CALCIUM
Route of administration
ORAL
Max daily dose
1 mg milligram(s)
Max total dose
252 mg milligram(s)
Max treatment duration
36 Week(s)
Authorisation status
Authorised
ATC code
B03BB01 — FOLIC ACID
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Anhydrous Caffeine

SCP4358000 · ATC

Active substance
Anhydrous Caffeine
Route of administration
ORAL
Max daily dose
3 g gram(s)
Max total dose
756 g gram(s)
Max treatment duration
36 Week(s)
Authorisation status
Authorised
ATC code
N02BE01 — PARACETAMOL
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

—

SCP189367 · ATC

Route of administration
ORAL
Max daily dose
400 mg milligram(s)
Max total dose
100 g gram(s)
Max treatment duration
36 Week(s)
Authorisation status
Authorised
ATC code
P01BA01 — CHLOROQUINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sulfasalazine

SCP1663308 · ATC

Active substance
Sulfasalazine
Substance synonyms
SULPHASALAZINE, SALICYLAZOSULFAPYRIDINE, SASP
Route of administration
ORAL
Max daily dose
2000 mg milligram(s)
Max total dose
504 g gram(s)
Max treatment duration
36 Week(s)
Authorisation status
Authorised
ATC code
A07EC01 — SULFASALAZINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

SCP6149474 · ATC

Pharmaceutical form
-
Route of administration
ORAL
Max daily dose
3200 mg milligram(s)
Max total dose
806 g gram(s)
Max treatment duration
36 Week(s)
Authorisation status
Authorised
ATC code
M01A — ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Methotrexate

SCP8282487 · ATC

Active substance
Methotrexate
Route of administration
ORAL
Max daily dose
25 mg milligram(s)
Max total dose
6300 mg milligram(s)
Max treatment duration
36 Week(s)
Authorisation status
Authorised
ATC code
L04AX03 — METHOTREXATE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

109 Total trials 22 Recruiting 86 Ended
Commercial
Sponsor organisation
Janssen - Cilag International
Address
Turnhoutseweg 30
City
Beerse
Postcode
2340
Country
Belgium

Scientific contact point

Organisation
Janssen - Cilag International
Contact name
CTIS Point of Contact

Public contact point

Organisation
Janssen - Cilag International
Contact name
CTIS Point of Contact

Third parties 12

OrganisationCity, countryDuties
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Clinical Trial Media Inc.
ORG-100046339
 Hauppauge, United States Other
Ancillare LP
ORG-100044089
 Horsham, United States Other
Labcorp Central Laboratory Services LP
ORG-100032236
 Indianapolis, United States Laboratory analysis
Icon Clinical Research Limited
ORG-100008322
 Dublin 18, Ireland Other
Almac
ORG-100013160
 Souderton, United States Code 14, Interactive response technologies (IRT)
Pra International
ORG-100031831
 Mannheim, Germany Other
Infinity Biologix LLC
ORG-100040369
 Piscataway, United States Laboratory analysis
Parexel International S.R.L.
ORG-100029949
 Bucharest, Romania Data management
Petska Biomedical Laboratories
ORL-000001705
 Piscataway, NJ, United States Laboratory analysis
Fortrea Inc.
ORG-100012602
 Durham, United States Code 8
Eresearchtechnology Inc.
ORG-100013039
 Philadelphia, United States Other

Locations

3 EU/EEA countries · 10 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Ended 20 1
Hungary Ended 15 5
Poland Ended 20 4
Rest of world
United Kingdom, Argentina, United States
 — 35 —

Investigational sites

Germany

1 site · Ended
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Hamburger Rheuma Forschungszentrum II, Moenckebergstrasse 27, Hamburg-Altstadt, Hamburg

Hungary

5 sites · Ended
Vasarhelyi Sarkanyfu Kft.
NA, Nagy Sandor Utca 11, 6800, Hodmezovasarhely
Budai Irgalmasrendi Korhaz Nonprofit Kft.
Rheumatology, Frankel Leo Ut 17-19, Kerulet, Budapest
Vital-Medicina Kft.
NA, Jozsef Attila Utca 17, 8200, Veszprem
Bekes Varmegyei Koezponti Korhaz
Rheumatology, Semmelweis Utca 1, 5700, Gyula
Complex Rendelo Med Zrt.
NA, Seregelyesi Ut 92, 8000, Szekesfehervar

Poland

4 sites · Ended
NZOZ Lecznica Mak Med s.c.
n/a, Ul. Wisniowa 22, 05-830, Nadarzyn
Klinika Reuma Park Sp. z o.o. S.K.
n/a, Aleja Wilanowska 333, 02-665, Warsaw
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Klinika Reumatologii i Układowych Chorób Tkanki Łącznej, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Warszawa, Ul Wronia 53 Lok B 10, 00-874, Warsaw

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Germany 2024-02-12 2024-10-29 2024-02-12 2024-02-19
Hungary 2024-02-08 2024-10-14 2024-02-08 2024-02-23
Poland 2024-02-09 2024-10-21 2024-02-09 2024-02-21

Results and documents

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

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
80202135ARA2002 (2023-504045-31-00) CR109343- Summary of results
SUM-103782
 2025-10-27T15:53:07 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
80202135ARA2002_PLS_01Sep2025_HUN_Hungarian 2025-10-27T15:53:24 Submitted Laypersons Summary of Results
80202135ARA2002_PLS_01Sep2025_POL_Polish 2025-10-27T15:53:15 Submitted Laypersons Summary of Results
80202135ARA2002_PLS_01Sep2025_DEU_German 2025-10-27T15:54:38 Submitted Laypersons Summary of Results

Documents 42 files

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

TypeTitleVersion
Laypersons summary of results (for publication) 80202135ARA2002_PLS_01Sep2025_DEU_German 1
Laypersons summary of results (for publication) 80202135ARA2002_PLS_01Sep2025_HUN_Hungarian 1
Laypersons summary of results (for publication) 80202135ARA2002_PLS_01Sep2025_POL_Polish 1
Protocol (for publication) 80202135ARA2002 Protocol REDACTED Am3
Protocol (for publication) Redacted_80202135ARA2002_Health Assessment Questionnaire_US English 4
Protocol (for publication) Redacted_80202135ARA2002_Pain VAS_US English 4
Protocol (for publication) Redacted_80202135ARA2002_Patient Global Assessment of Disease Activity _US English 4
Protocol (for publication) Redacted_80202135ARA2002_RA Joint Pain Severity Assessment_US English 4
Protocol (for publication) Redacted_HAQ-DI_ HUN_HUN_80202135ARA2002 1
Protocol (for publication) REDACTED_HAQ-DI_GER_GER_80202135ARA2002 1
Protocol (for publication) Redacted_Pain VAS_ HUN_HUN_80202135ARA2002 1
Protocol (for publication) REDACTED_Pain VAS_GER_GER_80202135ARA2002 draft
Protocol (for publication) Redacted_PtGA_ HUN_HUN_80202135ARA2002 1
Protocol (for publication) Redacted_RA Joint Pain Severity Assessment_ HUN_HUN_80202135ARA2002 1
Protocol (for publication) REDACTED_RA Joint Pain Severity Assessment_GER_GER_80202135ARA2002 1
Protocol (for publication) REDACTED_RA PtGA_GER_GER_80202135ARA2002 draft
Recruitment arrangements (for publication) REDACTED_Dr to Patient Email_PL_PL_80202135ARA2002 1
Recruitment arrangements (for publication) Redacted_Patient Recruitment Brochure_HUN_HUN_80202135ARA2002 1
Recruitment arrangements (for publication) REDACTED_Patient Recruitment Brochure_PL_PL_80202135ARA2002 1
Recruitment arrangements (for publication) REDACTED_Recruitment and Informed Consent Procedures_GER_ENG_80202135ARA2002 1
Recruitment arrangements (for publication) REDACTED_Recruitment and Informed Consent Procedures_PL_PL_80202135ARA2002 2
Recruitment arrangements (for publication) Redacted_Recruitment Flyer_HUN_HUN_80202135ARA2002 1
Recruitment arrangements (for publication) REDACTED_Recruitment Flyer_PL_PL_80202135ARA2002 1
Subject information and informed consent form (for publication) REDACTED_Clinical Informed Consent Form_GER_GER_80202135ARA2002 6
Subject information and informed consent form (for publication) Redacted_ICF Optional Genetic Research_HUN_HUN_80202135ARA2002 4
Subject information and informed consent form (for publication) Redacted_ICF_Main_HUN_HUN_80202135ARA2002 7
Subject information and informed consent form (for publication) Redacted_ICF_PP_HUN_HUN_80202135ARA2002 3
Subject information and informed consent form (for publication) Redacted_ICF_Withdrawal_HUN_HUN_80202135ARA2002 2
Subject information and informed consent form (for publication) REDACTED_Optional Genetic Research ICF_PL_PL_80202135ARA2002 2
Subject information and informed consent form (for publication) REDACTED_Patient Emergency Card_PL_PL_80202135ARA2002 1
Subject information and informed consent form (for publication) REDACTED_Patient Participation Card_GER_GER_80202135ARA2002 1
Subject information and informed consent form (for publication) REDACTED_Pharmacogenonic Consent Form_GER_GER_80202135ARA2002 2
Subject information and informed consent form (for publication) REDACTED_Pregnant Partner Consent Form_GER_GER_80202135ARA2002 1
Subject information and informed consent form (for publication) REDACTED_Pregnant Partner ICF_PL_PL_80202135ARA2002 1
Subject information and informed consent form (for publication) Redacted_Wallet Card_HUN_HUN_80202135ARA2002 2
Subject information and informed consent form (for publication) REDACTED_Withdrawal Consent Form_GER_GER_80202135ARA2002 1
Subject information and informed consent form (for publication) REDACTED_Withdrawal ICF_PL_PL_80202135ARA2002 1
Subject information and informed consent form (for publication) REDEACTED_Clinical ICF_PL_PL_80202135ARA2002 7
Summary of Product Characteristics (SmPC) (for publication) SmPC Cimzia 1
Summary of results (for publication) 80202135ARA2002 - 2023-504045-31-00- CR109343- Summary of results 14
Synopsis of the protocol (for publication) 80202135ARA2002 Protocol Synopsis - HU - REDACTED PAM3
Synopsis of the protocol (for publication) REDACTED_Protocol Synopsis_PL_PL_2023 504045 31 00_80202135ARA2002 PAM3

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-06-07 Poland Acceptable with conditions
2023-10-02
 2023-10-09
2 SUBSTANTIAL MODIFICATION SM-1 2023-10-23 Poland Acceptable
2024-02-05
 2024-02-07
3 SUBSTANTIAL MODIFICATION SM-2 2024-02-27 Poland Acceptable
2024-04-22
 2024-04-23
4 SUBSTANTIAL MODIFICATION SM-3 2024-07-30 Poland Acceptable
2024-09-10
 2024-09-13

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